70 results on '"Werschler WP"'
Search Results
2. Nonsurgical modalities to treat the aging face.
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Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM, Fitzgerald, Rebecca, Graivier, Miles H, Kane, Michael, Lorenc, Z Paul, Vleggaar, Danny, Werschler, Wm Philip, and Kenkel, Jeffrey M
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Injectable shaping agents include neurotoxins (botulinum toxin type A products), replacement fillers (hyaluronic acid [HA] agents), and biostimulatory fillers (calcium hydroxylapatite [CaHA], polymethylmethacrylate [PMMA], and poly-L-lactic acid [PLLA]). This article presents an overview of the agents currently available for use in facial rejuvenation in the United States. [ABSTRACT FROM AUTHOR]
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- 2010
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3. Facial aesthetic analysis.
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Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM, Fitzgerald, Rebecca, Graivier, Miles H, Kane, Michael, Lorenc, Z Paul, Vleggaar, Danny, Werschler, Wm Philip, and Kenkel, Jeffrey M
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Consideration of the individual patient's appearance based on systematic mapping and a three-dimensional evaluation of the four levels of facial structure (bone, muscle, fat, and skin) will help the clinician choose the most appropriate modalities for facial rejuvenation. This article addresses these concepts and also discusses universal perceptions of attractiveness. [ABSTRACT FROM AUTHOR]
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- 2010
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4. Appropriate selection and application of nonsurgical facial rejuvenation agents and procedures: panel consensus recommendations.
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Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM, Fitzgerald, Rebecca, Graivier, Miles H, Kane, Michael, Lorenc, Z Paul, Vleggaar, Danny, Werschler, Wm Philip, and Kenkel, Jeffrey M
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As injectable products have been introduced and as clinicians have gained experience with them, applications and techniques for injection have evolved, with better cosmetic results, enhanced patient safety, and greatly improved patient satisfaction. Within the past four years, several consensus recommendation panels have been convened to summarize the accumulated clinical experience and knowledge about the application of these products. The guidelines that already exist in the literature are referred to, and suggested guidelines for the administration of poly-L-lactic acid-for which no consensus guidelines have previously been published-are included in this article. [ABSTRACT FROM AUTHOR]
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- 2010
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5. Surgical versus nonsurgical rejuvenation.
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Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM, Fitzgerald, Rebecca, Graivier, Miles H, Kane, Michael, Lorenc, Z Paul, Vleggaar, Danny, Werschler, Wm Philip, and Kenkel, Jeffrey M
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The number of cosmetic procedures for facial rejuvenation has increased steadily over the past decade. The increase in the application of nonsurgical modalities, particularly injectable shaping agents, has been remarkable. As knowledge and experience about facial aging has increased, techniques and tools have improved, and it is increasingly apparent that surgical and nonsurgical/injectable modalities are complementary. [ABSTRACT FROM AUTHOR]
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- 2010
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6. Update on facial aging.
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Fitzgerald R, Graivier MH, Kane M, Lorenc ZP, Vleggaar D, Werschler WP, Kenkel JM, Fitzgerald, Rebecca, Graivier, Miles H, Kane, Michael, Lorenc, Z Paul, Vleggaar, Danny, Werschler, Wm Philip, and Kenkel, Jeffrey M
- Abstract
Facial aging was once thought to be the result of the relentless downward pull of gravity on skin and underlying fat. In turn, facial fat was believed to be a contiguous sheet of tissue. However, over the past four decades, a number of investigators have examined more closely the causes of facial aging, leading to a better understanding of age-related changes, and have confirmed and further explored the proposal by Gonzalez-Ulloa and Flores in 1965 that facial aging involves changes in muscle and bone, as well as skin and fat. Further, the recent work of Rohrich and Pessa (and other authors) has demonstrated that facial fat is not a sheet of tissue, but rather is compartmentalized throughout the face. This discovery has allowed the evolution of improved techniques for facial rejuvenation. [ABSTRACT FROM AUTHOR]
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- 2010
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7. Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Papulopustular Rosacea in Elderly Patients: Post-hoc Analysis of Results from Two Randomized, Phase III, Vehicle-controlled Trials.
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Green LJ, Baldwin H, Sugarman J, Andriopoulos B, Nov O, Levy-Hacham O, Bhatia N, and Werschler WP
- Abstract
Objective: We sought to compare the efficacy and safety of encapsulated benzoyl peroxide (E-BPO) cream, 5%, versus vehicle in subjects <65 years of age versus subjects ≥65 with moderate to severe papulopustular rosacea., Methods: This analysis used pooled results from two 12-week, randomized, vehicle-controlled Phase III trials (NCT03564119, NCT03448939) of E-BPO cream, 5%. These trials included 733 subjects randomized 2:1 to E-BPO or vehicle. The primary endpoints were success in the Investigator's Global Assessment (IGA) score and reduction in mean inflammatory lesion count at Week 12., Results: Our analysis shows that E-BPO cream, 5%, was significantly superior to vehicle in achieving IGA success and reducing inflammatory lesions in both age groups. IGA success was achieved in 48.3% of subjects who received E-BPO versus 25.4% for vehicle in the intent-to-treat population. The E-BPO and vehicle IGA success percentages for subjects <65 were 45.7% and 23.8%, respectively, and those for subjects ≥65 were 60.0% and 28.1%, respectively. The absolute reduction from baseline in inflammatory lesions was -19.3 for subjects who received E-BPO versus -11.4 for those who received vehicle. The E-BPO and vehicle absolute reduction values for subjects <65 were -19.6 and -11.2, respectively, and 17.5 and -10.4 for subjects ≥65. There were no significant differences in the frequencies of adverse events or cutaneous tolerability., Limitations: E-BPO was not compared to nonencapsulated BPO., Conclusion: This combined analysis of results from the two Phase III, randomized, double-blind controlled studies of E-BPO cream, 5%, showed it was efficacious, tolerable, and safe, regardless of age., Competing Interests: DISCLOSURES: Dr. Baldwin is an investigator, advisor, and speaker for Galderma; an investigator, advisor, and speaker for Bausch Health, and an investigator and advisor for Sol-Gel Technologies Ltd. Dr. Bhatia is an advisor, consultant, and investigator for Galderma and Sol-Gel Technologies Ltd. Dr. Green is an investigator, speaker, and consultant for Galderma and Ortho Dermatologics. Dr. Sugarman is a consultant for Sol-Gel Technologies Ltd., Galderma, and Bausch Health., (Copyright © 2024. Matrix Medical Communications. All rights reserved.)
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- 2024
8. Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis.
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Kircik LH, Stein Gold L, Gold M, Weiss JS, Harper JC, Del Rosso JQ, Bunick CG, Bhatia N, Tanghetti EA, Eichenfield LF, Baldwin H, Draelos ZD, Callender VD, Han G, Gooderham MJ, Sadick N, Lupo MP, Lain ET, and Werschler WP
- Abstract
Introduction: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data., Methods: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated., Results: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P < 0.001). CAB resulted in > 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12., Conclusions: The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products., Trial Registration: ClinicalTrials.gov identifier NCT04214639 and NCT04214652., (© 2024. The Author(s).)
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- 2024
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9. Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for moderate-to-severe acne: Efficacy and safety results from two randomized phase 3 trials.
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Stein Gold L, Lain E, Del Rosso JQ, Gold M, Draelos ZD, Eichenfield LF, Sadick N, Werschler WP, Gooderham MJ, and Lupo M
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Background: A three-pronged acne treatment approach-combining an antibiotic, antibacterial agent, and retinoid-may provide greater efficacy than single/double treatments. Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (IDP-126) is the first fixed-dose triple-combination in development for acne., Objective: To confirm efficacy, safety, and tolerability of IDP-126 gel in acne treatment., Methods: Two phase 3, double-blind, 12-week studies randomized participants aged ≥9 years with moderate-to-severe acne (N = 183; N = 180) 2:1 to once-daily IDP-126 or vehicle gel. Co-primary endpoints comprised participants achieving ≥2-grade reduction from baseline in Evaluator's Global Severity Score (EGSS) and clear/almost clear skin (treatment success) and change from baseline in inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed., Results: At week 12, 49.6% and 50.5% of participants achieved treatment success with IDP-126 versus 24.9% and 20.5% with vehicle (P < .01, both). IDP-126 also provided significantly greater reductions in inflammatory/noninflammatory lesions versus vehicle (least-squares mean percent range: 72.7% to 80.1% vs 47.6% to 59.6%; P < .001, all). Most TEAEs were of mild-moderate severity., Limitations: Inter-observer bias/variation in acne severity ratings, limited treatment duration, and population differences that may not generalize to real-world populations., Conclusion: The innovative fixed-dose, triple-combination IDP-126 gel was efficacious and well tolerated in 2 clinical studies of participants with moderate-to-severe acne., Competing Interests: Conflicts of interest Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis and Lilly. Edward Lain has served as an investigator, consultant and/or speaker for Ortho Dermatologics, AbbVie, Almirall, Amgen, Arcutis, Dermavant, EPI Health, Galderma, Incyte, LEO Pharma, Novartis, Eli Lilly, Pfizer, Sun Pharma, UCB, Endo International, ChemoCentryx, Biorasi, Sirnaomics, Evelo Biosciences, Concert Pharmaceuticals, Cara Therapeutics, Castle Biosciences, Mindera, Biofrontera, Alfasigma, AiViva Biopharma, Anaptys Bio, Bausch Health, Dr Reddy's, and Trevi Therapeutics. James Q. Del Rosso has served as a consultant, investigator, and/or speaker for Ortho Dermatologics, Abbvie, Amgen, Arcutis, Dermavant, EPI Heath, Galderma, Incyte, LEO Pharma, Lilly, MC2 Therapeutics, Pfizer, Sun Pharma, and UCB. Michael Gold has acted as an investigator, advisor, speaker, and consultant for Ortho Dermatologics. Zoe D. Draelos received funding from Ortho Dermatologics for research. Lawrence F. Eichenfield has received honoraria for consulting services from Almirall, Celgene, Dermira, Dermavant, Eli Lilly, Forte Pharma, Galderma, Incyte, Otsuka, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi Genzyme, and Ortho Dermatologics; and study support (to institution) from Bausch Health, Dermira, Eli Lilly and Company, Galderma, Incyte, Pfizer, Regeneron Pharmaceuticals, Inc, and Sanofi Genzyme. Neil Sadick has served on advisory boards, as a consultant, investigator, speaker, and/or other and has received honoraria and/or grants/research funding from Almirall, Actavis, Allergan, Anacor Pharmaceuticals, Auxilium Pharmaceuticals, Bausch Health, Bayer, Biorasi, BTG, Carma Laboratories, Cassiopea, Celgene Corporation, Cutera, Cynosure, DUSA Pharmaceuticals, Eclipse Medical, Eli Lilly and Company, Endo International, EndyMed Medical, Ferndale Laboratories, Galderma, Gerson Lehrman Group, Hydropeptide, Merz Aesthetics, Neostrata, Novartis, Nutraceutical Wellness, Palomar Medical Technologies, Prescriber's Choice, Regeneron, Roche Laboratories, Samumed, Solta Medical, Storz Medical AG, Suneva Medical, Vanda Pharmaceuticals, and Venus Concept. William Philip Werschler has served as an investigator for Ortho Dermatologics. Melinda J. Gooderham has served as investigator/consultant or speaker for AbbVie, Akros Pharma, Amgen, Arcutis Biotherapeutics, Aslan, Aristea, AnaptysBio, Bausch, BMS, Boehringer Ingelheim, Coherus BioSciences, Dermira, Dermavant, Eli Lilly, Galderma, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Meiji, Merck, Moonlake, Nimbus, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Sanofi, Sun Pharma, and UCB. Mary Lupo has served as a speaker, investigator, and/or on advisory boards for Ortho Dermatologics, Bausch Health US, Evolus, Revance, Eirion, Prolennium, Chemocentryx, Therapeutics Incorporated, Brickell, Endo, Cutera, In Mode, Revision, and Merz., (Copyright © 2023 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
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- 2023
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10. Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase III, Randomized, Vehicle-Controlled Trials.
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Bhatia ND, Werschler WP, Baldwin H, Sugarman J, Green LJ, Levy-Hacham O, Nov O, Ram V, and Stein Gold L
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Objective: A new formulation of benzoyl peroxide (E-BPO cream, 5%) entraps benzoyl peroxide (BPO) in silica microcapsules. This study assesses the efficacy, safety, and tolerability of E-BPO cream, 5%, in rosacea in two Phase III clinical trials., Methods: In two 12-week, randomized, double-blind, vehicle cream-controlled Phase III trials, 733 subjects at least 18 years old with moderate to severe rosacea were randomized (2:1) to once-daily E-BPO cream, 5%, or vehicle., Results: In Study 1, the proportion of subjects achieving IGA clear/almost clear at Week 12 was 43.5 percent for E-BPO cream, 5%, and 16.1 percent for vehicle. In Study 2, the respective values were 50.1 percent and 25.9 percent. In Study 1, the decrease in lesion count from baseline to Week 12 was -17.4 for E-BPO cream, 5%, versus -9.5 for vehicle. In Study 2, the respective values were -20.3 and -13.3 (all P <0.001). The difference was also significant at Week 2. There were no treatment-related serious adverse events; 1.4 percent of subjects (1.8% E-BPO cream, 5%, 0.4% vehicle) discontinued due to adverse events. Assessed local tolerability was found to be similar among subjects in both E-BPO and vehicle., E-BPO was not compared with unencapsulated BPO., Conclusion: E-BPO is an effective and well tolerated treatment for rosacea. Clinicaltrials.gov Identifiers: NCT03564119, NCT03448939., Competing Interests: DISCLOSURES: Dr. Baldwin is a consultant, investigator, and/or advisory board member for Galderma, Bausch Health, Almirall, Sun Pharma, La Roche Posay, and EPI. Dr. Bhatia is a consultant, investigator, and/or advisory board member for Abbvie, Almirall, Arcutis, Beiersdorf, Biofrontera, BMS, BI, Cara, Dermavant, EPI Health, Ferndale, Galderma, InCyte, ISDIN, J&J, LaRoche-Posay, Leo, Lilly, Ortho, Pfizer, Regeneron, Sanofi, SunPharma, and Verrica. Dr. Green is an investigator, speaker, and consultant for EPI Health, Galderma, Ortho Derm, and Sun Pharma. Drs. Levy-Hacham, Nov, and Ram report no conflicts of interest relevant to the content of this article. Dr. Stein Gold is an advisor, investigator, and speaker for Galderma, Ortho derm, Sun Pharma, and Almirall. Dr. Sugarman is a consultant for Sol Gel and Galderma. Dr. Werschler is a consultant, investigator, and advisory board member for Galderma., (Copyright © 2023. Matrix Medical Communications. All rights reserved.)
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- 2023
11. Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials.
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Werschler WP, Sugarman J, Bhatia N, Baldwin H, Green LJ, Nov O, Ram V, Levy-Hacham O, and Stein Gold L
- Abstract
Objective: We sought to assess the long-term safety and tolerability of microencapsulated benzoyl peroxide cream, 5% (E-BPO cream, 5%), in subjects with rosacea. Efficacy and tolerability have been previously demonstrated in two 12-week, randomized, double-blind, vehicle-controlled Phase III trials., Methods: In this open-label extension study (NCT03564145; clinicaltrials.gov), all subjects from the initial placebo-controlled Phase III trials could receive E-BPO cream, 5%, for up to an additional 40 weeks, up to a total of 52 weeks of E-BPO cream, 5%, exposure. If a subject was assessed at study visits as "clear" or "almost clear" using the 5-point Investigator Global Assessment (IGA) scale (IGA 0 or 1), E-BPO cream, 5%, was not dispensed. If a subject was assessed as "mild to severe" (IGA 2+), E-BPO cream, 5%, was applied daily until they reached "clear" or "almost clear.", Results: The safety and tolerability profile for E-BPO cream, 5%, was similar to that reported in the Phase III studies. Five subjects (0.9%) discontinued study drug due to treatment-related adverse events, and 17 subjects (3.2%) experienced an adverse event considered related to study drug. IGA success after 40 weeks of active treatment was 66.5 percent for subjects continuing from the Phase III vehicle group (n=172) and 67.6 percent for subjects who continued Phase III E-BPO cream, 5% (n=363). The study ended early in accordance with the protocol., Limitations: Safety and tolerability of E-BPO were not compared with those of unencapsulated BPO., Conclusion: E-BPO cream, 5%, showed a favorable safety and tolerability profile during this 40-week, open-label extension study., Competing Interests: DISCLOSURES: Dr. Sugarman is a consultant and speaker for Arcutis, Pfizer, Regeneron, Sanofi, and Incyte; a consultant for Bausch Heath and Sol-Gel; and a medical safety monitor for Galderma clinical research trials and Dermavant clinical studies. Dr. Bhatia is an advisor, consultant, investigator, and speaker for Galderma. Dr. Baldwin is a speaker at Galderma, Bausch Health, Almirall, EPI, and Sun Pharma. Dr. Green is a speaker, consultant, investigator for Galderma and Ortho Dermatologics. Mr. Ram reports no conflict of interest. Dr. Nov is an employee of Sol-Gel Technologies. Dr. Stein Gold is an investigator, speaker, and advisor for Galderma, Ortho Derm, Sun Pharma, and Almirall. Dr. Werschler, Mr. Ram, and Dr. Levy-Hacham report no conflict of interest., (Copyright © 2023. Matrix Medical Communications. All rights reserved.)
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- 2023
12. Triple-combination clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel for moderate-to-severe acne in children and adolescents: Randomized phase 2 study.
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Eichenfield LF, Stein Gold L, Kircik LH, Werschler WP, Beer K, Draelos ZD, Tanghetti EA, Papp KA, Baldwin H, Lain E, Sadick N, Gooderham MJ, and Konda A
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- Humans, Child, Adolescent, Infant, Newborn, Adapalene therapeutic use, Benzoyl Peroxide adverse effects, Quality of Life, Peroxides therapeutic use, Drug Combinations, Severity of Illness Index, Clindamycin adverse effects, Treatment Outcome, Gels therapeutic use, Double-Blind Method, Dermatologic Agents adverse effects, Acne Vulgaris drug therapy
- Abstract
Background/objectives: Topical clindamycin phosphate 1.2%/benzoyl peroxide 3.1%/adapalene 0.15% gel (IDP-126) is the first fixed-dose triple-combination formulation in development for acne. This post hoc analysis investigated efficacy and safety of IDP-126 in children and adolescents with moderate-to-severe acne., Methods: In a randomized, double-blind phase 2 study (NCT03170388), participants ≥9 years of age with moderate-to-severe acne were eligible for randomization (1:1:1:1:1) to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. This post hoc analysis of pediatric participants (n = 394) included children and adolescents up to 17 years of age. Assessments included treatment success, inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability., Results: At Week 12, treatment success rates were significantly greater with IDP-126 (55.8%) than with vehicle (5.7%; p < .001) or any of the dyad combinations (range: 30.8%-33.9%; p < .01, all). Lesion reductions with IDP-126 were also significantly greater than with vehicle (inflammatory: 78.3% vs. 45.1%; noninflammatory: 70.0% vs. 37.6%; p < .001, both) and 9.2%-16.6% greater than with any of the dyad combinations. Increases (improvements) from baseline in Acne-QoL domain scores were generally greater with IDP-126 than in any other treatment group. The most common treatment-related TEAEs across treatment groups were application site pain and dryness. Most treatment-related TEAEs were of mild-to-moderate severity., Conclusion: IDP-126 gel-a novel fixed-dose, triple-combination topical formulation for acne-demonstrated superior efficacy to vehicle and three dyad component gels and was well tolerated in children and adolescents with moderate-to-severe acne., (© 2023 The Authors. Pediatric Dermatology published by Wiley Periodicals LLC.)
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- 2023
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13. Efficacy and tolerability of three topical acne treatments by body mass index: post hoc analysis including overweight and obese patients.
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Keri J, Cook-Bolden FE, Green L, Kircik LH, Baldwin H, Werschler WP, Guenin E, Pillai R, and Bhatt V
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- Humans, Body Mass Index, Overweight complications, Overweight drug therapy, Thinness drug therapy, Severity of Illness Index, Double-Blind Method, Benzoyl Peroxide therapeutic use, Clindamycin, Tretinoin, Treatment Outcome, Emulsions, Obesity, Gels, Acne Vulgaris drug therapy, Acne Vulgaris pathology, Dermatologic Agents therapeutic use
- Abstract
Background: Acne prevalence may be higher in overweight/obese individuals, potentially due to hormonal, inflammatory, and/or dietary factors. However, the effects of body mass index (BMI) on topical acne treatments are largely unknown., Methods: Post hoc analyses of changes in inflammatory/noninflammatory lesions and treatment success were conducted using phase 3 data: clindamycin phosphate/benzoyl peroxide (CP/BPO) 1.2%/3.75% gel (NCT01701024); tretinoin 0.05% lotion (NCT02965456 and NCT02932306; pooled); and tazarotene 0.045% lotion (NCT03168321 and NCT03168334; pooled). Data were analyzed by BMI subgroups: <25kg/m
2 (underweight-to-normal), 25-<30kg/m2 (overweight), and ≥30kg/m2 (obese)., Results: Among participants analyzed (CP/BPO = 495; tretinoin = 1,636; tazarotene = 1,612), ∼20-25% were overweight and 15-20% were obese. At week 12, mean percent changes from baseline in inflammatory lesions were: CP/BPO (overweight: -63.2%, obese: -56.0%); tretinoin (-57.6%, -53.1%); tazarotene (-59.9%, -56.8%). Mean changes in noninflammatory lesions were: CP/BPO (-54.2%, -50.8%); tretinoin (-51.6%, -44.9%); tazarotene (-56.7%, -54.6%). Treatment success rates with active treatment ranged from 16.2% to 33.5% across BMI groups., Conclusions: CP/BPO 1.2%/3.75% gel, tretinoin 0.05% lotion, and tazarotene 0.045% lotion were all effective in reducing acne lesions by ≥45% in overweight/obese patients with moderate-to-severe acne, comparable to the underweight-to-normal group. Efficacy of these topical acne treatments is not greatly impacted by BMI and may be affected more by the formulation.- Published
- 2022
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14. Multimodal Facial Aesthetic Treatment on the Appearance of Aging, Social Confidence, and Psychological Well-being: HARMONY Study.
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Cohen JL, Rivkin A, Dayan S, Shamban A, Werschler WP, Teller CF, Kaminer MS, Sykes JM, Weinkle SH, and Garcia JK
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- Aging, Esthetics, Humans, Hyaluronic Acid, Infant, Patient Satisfaction, Prospective Studies, Treatment Outcome, Cosmetic Techniques, Skin Aging
- Abstract
Background: A global approach to facial rejuvenation involves multiple treatment modalities., Objectives: The aim of this study was to evaluate the impact of multimodal facial aesthetic treatment on self-reported psychological and social outcomes., Methods: HARMONY, a prospective, multicenter, 4-month study, enrolled patients aged 35 to 65 years to receive on-label treatment with a combination of hyaluronic fillers (VYC-20L, HYC-24L, and/or HYC-24L+), onabotulinumtoxinA, and bimatoprost. Fillers were injected on Day 1, with touch-ups performed on Day 14. OnabotulinumtoxinA was injected at Month 3 into glabellar lines and/or crow's feet lines. Patients applied bimatoprost to eyelashes once daily for 17 weeks. Mean change from baseline on FACE-Q Psychological Well-being and Social Confidence Scales, FACE-Q Aging Appearance Appraisal Scale, and FACE-Q Age Appraisal Visual Analog Scale were assessed., Results: Of 100 patients treated, 93 were evaluated at 4 months posttreatment. Significant improvement vs baseline was observed on the FACE-Q Scales for Psychological Well-being (mean change, -19.9; P < 0.00001), Social Confidence (mean change, -18.2; P < 0.00001), and Aging Appearance (mean change, -28.5; P < 0.0001). On average, patients' self-assessed age was 0.1 years older than actual age at baseline and 4.5 years younger at Month 4 (P < 0.001 vs baseline). Forty-two patients experienced adverse events, all mild to moderate., Conclusions: Multimodal, full facial aesthetic treatment improves patients' self-reported psychological well-being, social confidence, aging appearance, and perceptions of chronologic age., (© 2021 The Aesthetic Society.)
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- 2022
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15. Skin Tightening With Hyperdilute CaHA: Dilution Practices and Practical Guidance for Clinical Practice.
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Lorenc ZP, Black JM, Cheung JS, Chiu A, Del Campo R, Durkin AJ, Graivier M, Green JB, Kwok GP, Marcus K, Rammos CB, and Werschler WP
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- Biocompatible Materials, Calcium, Durapatite, Humans, Cellulite, Cosmetic Techniques, Skin Aging
- Abstract
Background: Over the past several years, hyperdilute calcium hydroxylapatite (CaHA) has emerged as an effective modality for improving skin quality and managing laxity in the face, arms, hands, neck, décolletage, upper arms, abdomen, buttocks, and upper legs, as well as for treating cellulite and striae. Whereas undiluted CaHA is used to provide volume, hyperdilute CaHA is distributed across a much larger surface area in a more superficial plane to stimulate neocollagenesis and elastin formation over time. The absence of lymphocytic infiltrates and predominance of type 1 collagen in the tissue response to CaHA make hyperdilute CaHA a valuable tool for nonsurgical skin tightening., Objectives: The aim of this study was to provide practical step-by-step guidance on patient selection, dilution practices, and optimal injection technique to facilitate incorporation of the technique into clinical practice., Methods: Over the course of 3 regional meetings in the United States, 12 expert physician injectors participated in live webinars as part of a continuing medical education program., Results: The practical guidance in this manuscript is based upon the most frequently requested information by audience members and the information considered critical for success by the authors., Conclusions: The minimally invasive nature of filler injection results in little downtime, making this treatment particularly appealing. The recommendations presented are consistent with previously published consensus guidelines on hyperdilute CaHA but are intended to serve as "how-to" guidance based on the experience of expert injectors who have successfully treated the face and body., (© 2021 The Aesthetic Society.)
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- 2022
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16. Tolerability of tretinoin lotion 0.05% for moderate to severe acne vulgaris: a post hoc analysis in a black population.
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Bhatia ND, Werschler WP, Cook-Bolden FE, and Guenin E
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- Administration, Cutaneous, Adolescent, Adult, Child, Dermatologic Agents adverse effects, Double-Blind Method, Female, Follow-Up Studies, Humans, Hyperpigmentation drug therapy, Male, Middle Aged, Severity of Illness Index, Skin Cream, Tretinoin adverse effects, Young Adult, Acne Vulgaris drug therapy, Black People, Dermatologic Agents administration & dosage, Tretinoin administration & dosage
- Abstract
Acne vulgaris (acne) is the most common dermatologic disorder seen in black patients. However, data are lacking on the effects of treatments, such as topical retinoids. Acne in black patients is frequently associated with postinflammatory hyperpigmentation (PIH), which can be of greater concern than the patient's acne and often is the main reason these patients seek a dermatologist consultation. Retinoids can treat both acne and PIH. However, the potential for retinoids to induce an irritant contact dermatitis, which could lead to PIH, is a concern. A lotion formulation of tretinoin was developed to provide an important alternative option to treat acne in black patients who may be sensitive to the irritant effects of other tretinoin formulations or where PIH is a concern.
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- 2020
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17. Maximizing Panfacial Aesthetic Outcomes: Findings and Recommendations From the HARMONY Study.
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Kaminer MS, Cohen JL, Shamban A, Werschler WP, Shumate GT, Drinkwater A, and Gallagher CJ
- Subjects
- Administration, Topical, Adult, Aged, Dermal Fillers administration & dosage, Esthetics, Evidence-Based Medicine methods, Evidence-Based Medicine standards, Face physiology, Female, Humans, Hyaluronic Acid administration & dosage, Injections, Subcutaneous, Male, Middle Aged, Neuromuscular Agents administration & dosage, Ophthalmic Solutions administration & dosage, Patient Reported Outcome Measures, Patient Satisfaction, Practice Guidelines as Topic, Skin drug effects, Skin Aging drug effects, Skin Aging physiology, Treatment Outcome, Bimatoprost administration & dosage, Botulinum Toxins, Type A administration & dosage, Cosmetic Techniques standards, Hyaluronic Acid analogs & derivatives, Rejuvenation
- Abstract
Background: Aesthetic medicine has evolved from targeting individual treatment areas to a global approach of panfacial rejuvenation. HARMONY was the first clinical study to systematically demonstrate positive physical and psychosocial impacts of panfacial treatment., Objective: Provide evidence-based guidance on treatment strategies to help maximize outcomes in patients seeking panfacial rejuvenation., Materials and Methods: Study sites with the lowest (n = 2) and highest (n = 2) improvements based on FACE-Q Satisfaction with Face Overall scores were analyzed to understand differences in treatment strategy that may contribute to incrementally greater patient satisfaction., Results: The highest scoring sites exhibited greater improvement in all patient-reported outcomes and investigator-assessed measures related to dermal filler treatment compared with the lowest scoring sites. The highest sites favored lateral malar augmentation and used less volume medially versus the lowest sites. In the lower face, the highest sites used greater volumes and more HYC-24L than HYC-24L+. Initial treatment volumes were more conservative at highest than lowest sites; greater volumes were used by highest sites in touch-up treatments., Conclusion: Product usage trends common to the highest scoring sites (including injection volume, injection sites, and product selection) may provide guidance on best practices for a panfacial approach to aesthetic treatment to maximize patient satisfaction.
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- 2020
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18. Novel Polymeric Lotion Formulation of Once-Daily Tazarotene (0.045%) for Moderate-to-Severe Acne: Pooled Phase 3 Analysis.
- Author
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Tanghetti EA, Werschler WP, Lain E, Guenin E, Harris S, Loncaric A, and Pillai R
- Subjects
- Acne Vulgaris diagnosis, Adolescent, Adult, Aged, Child, Clinical Trials, Phase III as Topic, Double-Blind Method, Emulsions administration & dosage, Emulsions adverse effects, Emulsions chemistry, Female, Humans, Keratolytic Agents adverse effects, Keratolytic Agents chemistry, Male, Middle Aged, Nicotinic Acids adverse effects, Pain chemically induced, Polymers chemistry, Quality of Life, Randomized Controlled Trials as Topic, Severity of Illness Index, Skin Cream adverse effects, Skin Cream chemistry, Treatment Outcome, Young Adult, Acne Vulgaris drug therapy, Keratolytic Agents administration & dosage, Nicotinic Acids administration & dosage, Pain epidemiology, Skin Cream administration & dosage
- Abstract
Background: As current tazarotene formulations indicated for acne (0.1%) can cause irritation, a new tazarotene 0.045% lotion formu-lation was developed using polymeric emulsion technology. The objective was to assess efficacy, safety, and tolerability of tazarotene 0.045% lotion in patients with moderate-to-severe acne in a pooled analysis of data from two identical phase 3, double-blind, random-ized, vehicle-controlled 12-week clinical studies. Methods: Patients aged ≥9 years with moderate-to-severe acne were randomized (1:1) to tazarotene 0.045% lotion or vehicle lotion applied once daily. Inflammatory and noninflammatory lesion counts and Evaluator's Global Severity Score (EGSS) were assessed. Treatment success was defined as a ≥2-grade improvement in EGSS and a score of 'clear'/'almost clear'. Adverse events (AEs) and cutaneous safety and tolerability were also assessed. Results: In total, 1614 patients (mean age: 20.5 years) were randomized to tazarotene 0.045% lotion (n=799) or vehicle (n=815). At week 12, tazarotene 0.045% lotion demonstrated statistically significant superiority versus vehicle in reducing inflammatory and non-inflammatory lesion counts (least-squares mean percent changes from baseline: inflammatory, -57.9% vs -47.8% [P<0.001]; noninflam-matory, -56.0% vs -42.0% [P<0.001]). Treatment success at week 12 was also greater with tazarotene 0.045% lotion versus vehicle (30.4% vs 17.9%; P<0.001). The most frequent treatment-emergent AEs related to tazarotene treatment were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). Conclusions: The new tazarotene 0.045% lotion formulated with polymeric emulsion technology demonstrated statistically signifi-cantly superior efficacy versus vehicle and was well tolerated in pediatric and adult patients with moderate-to-severe acne in this pooled analysis of 2 vehicle-controlled phase 3 studies. J Drugs Dermatol. 2020;19(3):272-279. doi:10.36849/JDD.2020.4869.
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- 2020
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19. Tazarotene 0.045% Lotion for Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris: Results from Two Phase 3 Trials
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Tanghetti EA, Werschler WP, Lain T, Guenin E, Martin G, and Pillai R
- Subjects
- Acne Vulgaris pathology, Administration, Cutaneous, Adolescent, Adult, Child, Double-Blind Method, Female, Humans, Male, Middle Aged, Quality of Life, Severity of Illness Index, Skin Cream, Surveys and Questionnaires, Treatment Outcome, Young Adult, Acne Vulgaris drug therapy, Dermatologic Agents administration & dosage, Nicotinic Acids administration & dosage
- Abstract
BACKGROUND: Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne), with data suggesting that is one of the most potent topical retinoids. Irritation from the cream, foam, and gel formulations has limited its use in clinical practice. OBJECTIVE: To assess the efficacy, safety, and tolerability of a unique tazarotene 0.045% lotion formulation based on polymeric emulsion technology in subjects with moderate or severe acne. Methods: A total of 1614 subjects, 9 years and older were randomized to receive tazarotene 0.045% lotion or vehicle in two identical double-blind, randomized, vehicle-controlled 12-week studies evaluating safety and efficacy (inflammatory [papules and pustules] and noninflammatory [comedonal] lesion counts and using Evaluator Global Severity Scores [EGSS]). Treatment success was defined as at least a 2-grade improvement in EGSS and ‘clear’/’almost clear’ and efficacy assessed through reduction in lesion counts. In addition, patients completed a validated Acne-Specific Quality of Life (Acne-QoL) questionnaire. Safety, adverse events (AEs), and cutaneous tolerability were assessed throughout. RESULTS: Tazarotene 0.045% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts at week 12. Mean percent reductions in inflammatory and noninflammatory lesions were 55.5% and 51.4% (Study 1, both P<0.001 versus vehicle [45.7% and 41.5%, respectively]) and 59.5% and 60.0% (Study 2, both P<0.001 versus vehicle [49.0% and 41.6%, respectively]), with tazarotene 0.045% lotion at week 12. Treatment success was achieved by 25.5% (Study 1) and 29.6% (Study 2) of subjects treated with tazarotene 0.045% lotion (both P<0.001 versus vehicle [13.0% and 17.3%, respectively]). Improvements in QoL domain scores were consistently greater with tazarotene. Tazarotene 0.045% lotion was well-tolerated. The most common treatment-related AEs were application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%). CONCLUSION: Tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction and treatment success, with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. JJ Drugs Dermatol. 2020;19(1):70-77. doi:10.36849/JDD.2020.3977
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- 2020
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20. A 44-Week Open-Label Study Evaluating Safety and Efficacy of Topical Glycopyrronium Tosylate in Patients with Primary Axillary Hyperhidrosis.
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Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok RD, Quiring J, Drew J, and Pariser DM
- Subjects
- Administration, Cutaneous, Adolescent, Adult, Axilla, Child, Cholinergic Antagonists adverse effects, Double-Blind Method, Female, Follow-Up Studies, Glycopyrrolate adverse effects, Humans, Male, Quality of Life, Sweating drug effects, Treatment Outcome, Young Adult, Cholinergic Antagonists administration & dosage, Glycopyrrolate administration & dosage, Hyperhidrosis drug therapy, Severity of Illness Index
- Abstract
Background: Glycopyrronium tosylate is a topical anticholinergic approved in the USA for primary axillary hyperhidrosis in patients aged ≥ 9 years (Qbrexza™ [glycopyrronium] cloth, 2.4%)., Objective: This 44-week open-label extension study assessed glycopyrronium tosylate safety and descriptive efficacy in patients completing one of two, phase III, double-blind, vehicle-controlled, 4-week trials (NCT02530281; NCT02530294)., Methods: Patients aged ≥ 9 years with primary axillary hyperhidrosis were randomized 2:1 (glycopyrronium tosylate: vehicle, once daily) in the double-blind trials. Completers could receive open-label glycopyrronium tosylate for up to an additional 44 weeks. Treatment-emergent adverse events and local skin reactions were assessed. Descriptive efficacy assessments were gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale responder rate (≥ 2 grade improvement), and Dermatology Life Quality Index/children's Dermatology Life Quality Index., Results: Of 651 patients completing the double-blind trials, 564 (86.6%) entered the open-label extension; 550 were analyzed. Most patients experiencing treatment-emergent adverse events had mild or moderate events (> 90%). Discontinuation because of treatment-emergent adverse events remained low and relatively stable, with a cumulative rate of 8.0% (44/550) over 44 weeks. Common treatment-emergent adverse events (> 5%) were dry mouth (16.9%), vision blurred (6.7%), application-site pain (6.4%), nasopharyngitis (5.8%), and mydriasis (5.3%). Most patients (67.5%) had no local skin reactions; those occurring were predominantly mild/moderate. Glycopyrronium tosylate efficacy was maintained throughout the trial; at week 44, the Hyperhidrosis Disease Severity Scale responder rate was 63.2%, and improvements from baseline (double blind) in sweat production were - 71.3% and 8.7 ± 6.2/6.2 ± 4.9 for Dermatology Life Quality Index/children's Dermatology Life Quality Index., Conclusions: Daily long-term application of glycopyrronium tosylate for up to 48 weeks (double blind plus open label) was generally well tolerated and efficacy was maintained. No new safety signals emerged., Trial Registry: Clinicaltrials.gov NCT02553798.
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- 2019
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21. Glycopyrronium tosylate in pediatric primary axillary hyperhidrosis: Post hoc analysis of efficacy and safety findings by age from two phase three randomized controlled trials.
- Author
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Hebert AA, Glaser DA, Green L, Werschler WP, Forsha DW, Drew J, Gopalan R, and Pariser DM
- Subjects
- Administration, Topical, Adolescent, Adult, Aged, Axilla physiopathology, Child, Female, Germany, Glycopyrrolate adverse effects, Humans, Male, Middle Aged, Muscarinic Antagonists adverse effects, Quality of Life, Randomized Controlled Trials as Topic, Severity of Illness Index, Treatment Outcome, United States, Young Adult, Glycopyrrolate therapeutic use, Hyperhidrosis drug therapy, Muscarinic Antagonists therapeutic use
- Abstract
Objectives: Hyperhidrosis in pediatric patients has been understudied. Post hoc analyses of two phase 3 randomized, vehicle-controlled, 4-week trials (ATMOS-1 [NCT02530281] and ATMOS-2 [NCT02530294]) were performed to assess efficacy and safety of topical anticholinergic glycopyrronium tosylate (GT) in pediatric patients., Methods: Patients had primary axillary hyperhidrosis ≥ 6 months, average Axillary Sweating Daily Diary (ASDD/ASDD-Children [ASDD-C]) Item 2 (sweating severity) score ≥ 4, sweat production ≥ 50 mg/5 min (each axilla), and Hyperhidrosis Disease Severity Scale (HDSS) ≥ 3. Coprimary end points were ≥ 4-point improvement on ASDD/ASDD-C Item 2 (a validated patient-reported outcome) and change in gravimetrically measured sweat production at Week 4. Efficacy and safety data are shown through Week 4 for the pediatric (≥ 9 to ≤ 16 years) vs older (> 16 years) subgroups., Results: Six hundred and ninety-seven patients were randomized in ATMOS-1/ATMOS-2 (GT, N = 463; vehicle, N = 234); 44 were ≥ 9 to ≤ 16 years (GT, n = 25; vehicle, n = 19). Baseline disease characteristics were generally similar across subgroups. GT-treated pediatric vs older patients had comparable improvements in ASDD/ASDD-C Item 2 (sweating severity) responder rate, HDSS responder rate (≥ 2-grade improvement]), sweat production, and quality of life (mean change from Baseline in Dermatology Life Quality Index [DLQI]/children's DLQI), with greater improvement vs vehicle. Treatment-emergent adverse events were similar between subgroups, and most were mild, transient, and infrequently led to discontinuation., Conclusions: Topical, once-daily GT improved disease severity (ASDD/ASDD-C, HDSS), sweat production, and quality of life (DLQI), with similar findings in children, adults, and the pooled population. GT was well tolerated, and treatment-emergent adverse events were qualitatively similar between subgroups and consistent with other anticholinergics., (© 2018 The Authors. Pediatric Dermatology Published by Wiley Periodicals, Inc.)
- Published
- 2019
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22. Topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Results from the ATMOS-1 and ATMOS-2 phase 3 randomized controlled trials.
- Author
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Glaser DA, Hebert AA, Nast A, Werschler WP, Green L, Mamelok R, Drew J, Quiring J, and Pariser DM
- Subjects
- Administration, Topical, Adult, Axilla, Cholinergic Antagonists administration & dosage, Double-Blind Method, Female, Glycopyrrolate administration & dosage, Humans, Male, Cholinergic Antagonists therapeutic use, Glycopyrrolate therapeutic use, Hyperhidrosis drug therapy
- Abstract
Background: Glycopyrronium tosylate (GT) is a topical anticholinergic developed for once-daily treatment of primary axillary hyperhidrosis., Objective: Assess the efficacy and safety of GT for primary axillary hyperhidrosis., Methods: ATMOS-1 and ATMOS-2 were replicate randomized, double-blind, vehicle-controlled, 4-week phase 3 trials. Patients were randomized 2:1 to GT 3.75% or vehicle applied once daily to each axilla for 4 weeks. Coprimary endpoints were responder rate (≥4-point improvement from baseline) on item 2 (severity of sweating) of the Axillary Sweating Daily Diary (ASDD), which is a newly developed patient-reported outcome measure, and absolute change from baseline in axillary gravimetric sweat production at week 4. Safety evaluation included treatment-emergent adverse events., Results: Pooled data, which are consistent with the individual trial results, show that significantly more GT-treated patients achieved an ASDD-Item 2 response than did those treated with vehicle (59.5% vs 27.6%), and they had reduced sweat production from baseline (-107.6 mg/5 min vs -92.1 mg/5 min) at week 4 (P < .001 for both coprimary end points). Most treatment-emergent adverse events were mild or moderate and infrequently led to discontinuation., Limitations: Short trial duration and inherent challenges in gravimetrically assessing sweat production., Conclusions: GT applied topically on a daily basis over 4 weeks reduced the severity of sweating as measured by ASDD-Item 2, reduced sweat production as measured gravimetrically, and was generally well tolerated in patients with primary axillary hyperhidrosis., (Copyright © 2018 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2019
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23. BPX-01 Minocycline Topical Gel Shows Promise for the Treatment of Moderate-to-severe Inflammatory Acne Vulgaris.
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Alexis A, Del Rosso JQ, Desai SR, Downie JB, Draelos ZD, Feser C, Forconi R, Fowler JF Jr, Gold M, Kaufman-Janette J, Lain E, Lee M, Ling M, Shamban AT, Werschler WP, and Daniels A
- Abstract
Background and objectives: Acne vulgaris is a highly prevalent and multifactorial skin disorder that can adversely impact health-related quality of life. Factors that contribute to the pathogenesis of acne include pilosebaceous proliferation of proinflammatory Propionibacterium acnes ( P. acnes ) bacteria, presence of circulating androgens, excess sebum production, abnormal follicular keratinization, and multiple inflammatory cascades. Oral tetracyclines-especially doxycycline and minocycline-are frequently prescribed for the treatment of moderate-to-severe acne, given their anti-inflammatory properties and their effect on P. acnes reduction. Notwithstanding their established efficacy in the management of acne vulgaris, there is a desire to limit systemic exposure to antibiotics given growing concerns regarding bacterial resistance as well as the potential for serious side effects. This report describes outcomes of two randomized, vehicle-controlled trials (Phases IIa and IIb) of BPX-01, a topical minocycline gel, in the treatment of moderate-to-severe acne. Methods: In Study 1 (NCT02709096), at a single center, 33 subjects with highly fluorescing facial skin were randomized 2:1 to BPX-01 1% or vehicle control once-daily treatment for four weeks. Changes in P. acnes quantitative bacteriological cultures were assessed, as well as cutaneous tolerance to the study drug by both subjects and the investigator. In Study 2 (NCT02815332), subjects with moderate-to-severe inflammatory nonnodular acne (n=226) at 15 centers were randomized 1:1:1 to treatment with BPX-01 1%, BPX-01 2%, or vehicle control once-daily for 12 weeks. The primary endpoint was reduction in the number of inflammatory lesions; other endpoints included the number of noninflammatory lesions, Investigator's Global Assessment (IGA) of severity, and subjective ratings (investigator and subject) of acne. In both studies, cutaneous tolerability and safety were assessed, and plasma minocycline levels were tracked with a highly sensitive assay. Results: In Study 1, BPX-01 treatment reduced P. acnes colonization by 90.9 percent, which exceeded the reduction in the vehicle control group (65.53%; p =0.020). In Study 2, treatment with BPX-01 2% reduced the number of inflammatory lesions by 58.5 percent, exceeding the reduction in the vehicle control group (43.8%; p =0.0256). Trends toward an improvement preferential to BPX-01 2% were observed in the other endpoints. Across both studies, BPX-01 treatment was well-tolerated, with no photosensitivity, postinflammatory hyperpigmentation, or skin discoloration reported. A single subject (out of 259 study participants ) was identified to have detectable levels of plasma minocycline at low levels (42ng/mL) after 12 weeks of treatment but had no signs or symptoms associated with systemic administration of minocycline. Conclusion: BPX-01 appears to exhibit an effectiveness profile for reduction of inflammatory (nonnodular) acne lesions similar to that of oral minocycline formulations. However, because BPX-01 is topical and exhibits negligible systemic exposure, the likelihood of adverse events associated with oral minocycline use is much lower. These results demonstrate effectiveness of BPX-01 topical minocycline gel in reducing P. acnes colonization, suggesting that the BPX-01 2% formulation is a promising treatment for moderate-to-severe nonnodular, inflammatory acne vulgaris in both reduction of inflammatory lesions and also overall improvement in facial acne according to IGA., Competing Interests: FUNDING:This study was sponsored and funded by BioPharmX Inc. (Menlo Park, California). DISCLOSURES:All authors except Ms. Daniels are consultants of BioPharmX and were compensated fair market value for participation in this study as investigators. Ms. Daniels is an employee of BioPharmX.
- Published
- 2018
24. Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines.
- Author
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De Boulle K, Werschler WP, Gold MH, Bruce S, Sattler G, Ogilvie P, Street J, Larsen KE, Yushmanova I, Lei X, Lee E, Vitarella D, and Mao C
- Subjects
- Botulinum Toxins, Type A administration & dosage, Double-Blind Method, Female, Humans, Injections, Male, Middle Aged, Neuromuscular Agents administration & dosage, Treatment Outcome, Botulinum Toxins, Type A therapeutic use, Cosmetic Techniques, Face, Neuromuscular Agents therapeutic use, Skin Aging drug effects
- Abstract
Background: Although commonly practiced, simultaneous onabotulinumtoxinA injections to multiple facial areas have not been investigated in prospective studies., Objective: Evaluate safety and efficacy of onabotulinumtoxinA for treatment of forehead lines (FHL) distributed between the frontalis (20 U) and glabellar complex (20 U), with or without simultaneous lateral canthal areas (crow's feet lines [CFL], 24 U) treatment., Methods: Subjects with moderate to severe FHL were randomized (2:2:1) to onabotulinumtoxinA 40 U, onabotulinumtoxinA 64 U, or placebo. After 180 days, subjects could receive up to 2 additional open-label onabotulinumtoxinA 64 U treatments., Results: The intent-to-treat (ITT) population comprised 787 subjects, and the modified ITT (mITT) population (subjects with psychological impact) comprised 568. After 30 days, onabotulinumtoxinA 40 U and 64 U significantly improved investigator- and subject-assessed FHL severity by at least 2 Facial Wrinkle Scale (FWS) grades in 45.6% and 53.0% of ITT subjects, respectively, versus 0.6% receiving placebo (both, p < .0001). Significantly more mITT subjects receiving onabotulinumtoxinA achieved investigator- and subject-assessed FWS ratings of none/mild versus placebo (p < .0001). OnabotulinumtoxinA was well tolerated., Conclusion: OnabotulinumtoxinA distributed between the frontalis and glabellar complex, with or without additional CFL injections, was safe and effective for treatment of moderate to severe FHL.
- Published
- 2018
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25. Patient-perceived Emotional and Functional Benefits of Poly-L-Lactic Acid (PLLA) for the Treatment of Facial Volume Loss.
- Author
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Fried R, Werschler WP, Cenci J, Sternberg L, Dhanaraj P, Tolas D, and Withrow S
- Abstract
Background: Facial volume loss can substantially impact self-perception of the affected individual and his to her social/professional interactions and opportunities. Persons who are perceived as more youthful and attractive are rated as nicer, more energetic, healthier, and more likely to be productive than those perceived to be older and unattractive. Objective: The goal of this study was to assess the changes in emotional and functional status of subjects treated with 2 to 4 monthly PLLA injections to the upper, mid, and lower face. Methods: Fifty subjects were recruited from two community dermatology centers in the United States (Bucks County, Pennsylvania, and Spokane, Washington). Two patient self-report measures were used-The Facial Volume Restoration Outcome Questionnaire and the Rosenberg Self Esteem Scale. Results: Approximately 30 percent of the subjects who completed pre- and post-injection instruments reported increased confidence, increased sense of control, more comfort with others, increased happiness when looking in the mirror, more happiness when their faces were touched, healthier eating, increased contentment, beliefs that they were seen as less stressed by others, increased happiness with their bodies, exercising more, and that their lives were better. Additionally, 43 percent felt more optimistic and 33 percent felt less anxious. The changes in self-esteem, which was self-reported on the Rosenberg scale, were very modest but also favorable. Investigator's Global Assessment (IGA) of facial volume loss improved from 2.2 at baseline to 1.2 at six-month follow-up assessment. Conclusion: Treatment of facial volume loss with PLLA was associated with improvements in patient-perceived emotional and functional status at six months after initial injection., Competing Interests: FUNDING:Financial support was received from Galderma for this study. DISCLOSURES:Dr. Fried has served as a consultant, researcher, and/or speaker for Galderma, Allergan, Pfizer, Jannsen, Sun Pharmaceuticals, and Johnson & Johnson. All other authors have no conflicts of interest to disclose.
- Published
- 2018
26. Impact of Comprehensive, Minimally Invasive, Multimodal Aesthetic Treatment on Satisfaction With Facial Appearance: The HARMONY Study.
- Author
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Weinkle SH, Werschler WP, Teller CF, Sykes JM, Shamban A, Rivkin A, Narurkar VA, Kaminer MS, Dayan S, Cohen JL, and Gallagher CJ
- Subjects
- Adult, Combined Modality Therapy methods, Esthetics, Face, Female, Humans, Injections, Intramuscular, Injections, Subcutaneous, Male, Middle Aged, Patient Satisfaction, Prospective Studies, Self Concept, Skin Aging, Treatment Outcome, Bimatoprost administration & dosage, Botulinum Toxins, Type A administration & dosage, Cosmetic Techniques, Dermal Fillers administration & dosage, Rejuvenation
- Abstract
Background: Individuals seeking aesthetic treatment have concerns regarding multiple facial areas., Objectives: Assess the aesthetic impact and satisfaction achieved with a multimodal approach to aesthetic treatment using a combination of minimally invasive treatments., Methods: Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crow's feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale., Results: Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients., Conclusions: Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance.
- Published
- 2018
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27. Adapalene/Benzoyl Peroxide Gel 0.3%/2.5%: Effective Acne Therapy Regardless of Age or Gender.
- Author
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Stein Gold L, Werschler WP, and Mohawk J
- Subjects
- Acne Vulgaris pathology, Adapalene, Benzoyl Peroxide Drug Combination administration & dosage, Adapalene, Benzoyl Peroxide Drug Combination adverse effects, Administration, Cutaneous, Adolescent, Age Factors, Child, Dermatologic Agents administration & dosage, Dermatologic Agents adverse effects, Double-Blind Method, Drug Combinations, Female, Gels, Humans, Male, Sex Factors, Treatment Outcome, Acne Vulgaris drug therapy, Adapalene, Benzoyl Peroxide Drug Combination therapeutic use, Dermatologic Agents therapeutic use, Skin pathology
- Abstract
BACKGROUND: Acne vulgaris affects a diverse group of people, and there is an increasingly wide variety of acne treatments. Because of the many options, clinicians have a better ability to individualize treatment; however, achieving optimal results relies on understanding how various agents perform in specific population segments. Fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy and is available in two adapalene concentrations (0.1% and 0.3%) combined with BPO 2.5%. This analysis investigated whether gender and age have an impact on either the efficacy or safety of topical A/BPO 0.3%.
METHODS: A post-hoc subanalysis was performed on data from a multicenter, randomized, double-blind, parallelgroup, 12-week study of A/BPO gel 0.3%/2.5% or vehicle gel in subjects ≥ 12 years old with moderate to severe acne vulgaris (Investigator global assessment [IGA] of 3 or 4). Efficacy measurements included achievement of an IGA of clear (0) or almost clear (1), and change in lesion counts from baseline to week 12. Safety measures included adverse events and cutaneous tolerability. The intent to treat (ITT) and safety populations were analyzed.
RESULTS: The A/BPO gel 0.3%/2.5% treatment group included 217 subjects. Among the subjects, 111 were 12-17 years old and 106 were ≥ 18 years old; 104 were male and 113 were female. A/BPO 0.3%/2.5% was safe, tolerable, and significantly superior to vehicle in success rates (IGA 0 or 1) and reduction of inflammatory/noninflammatory lesions (P≤0.05) across both age groups and genders.
CONCLUSIONS: A/BPO 0.3%/2.5% treatment achieved success and was equally effective and safe in younger vs older subjects and in males vs females. These results support the use of A/BPO 0.3%/2.5% in all subjects 12 and older.
Clinicaltrials.gov registry: (NCT01880320)
J Drugs Dermatol. 2017;16(6):582-589.
.- Published
- 2017
28. High-dose Rate Electronic Brachytherapy: A Nonsurgical Treatment Alternative for Nonmelanoma Skin Cancer.
- Author
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Bhatnagar A, Patel R, Werschler WP, Ceilley RI, and Strimling R
- Abstract
The authors summarized data from a group of physicians with experience using high-dose rate electronic brachytherapy for the treatment of nonmelanoma skin cancer. The data have been published or presented in abstract format at national dermatology and radiation oncology meetings. The data included 1,822 treated lesions from 2009 to 2014 in patients ranging in age from 52 to 104 years. Most lesions were basal cell carcinoma (57%) or squamous cell carcinoma (38%) less than 2cm in size (97%). Median follow-up at the various centers ranged from 4 to 16 months, and results yielded an extremely low recurrence rate of less than one percent. Results show that within the confines of this follow up period, electronic brachytherapy is an effective, convenient, nonsurgical treatment option for patients with nonmelanoma skin cancer with few recurrences and excellent cosmetic results.
- Published
- 2016
29. Consensus Recommendations for Combined Aesthetic Interventions Using Botulinum Toxin, Fillers, and Microfocused Ultrasound in the Neck, Décolletage, Hands, and Other Areas of the Body.
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Fabi SG, Burgess C, Carruthers A, Carruthers J, Day D, Goldie K, Kerscher M, Nikolis A, Pavicic T, Rho NK, Rzany B, Sattler S, Seo K, Werschler WP, and Sattler G
- Abstract
Background: The popularity of aesthetic procedures in the face has led to greater disparity between treated areas and those that still show evidence of true age. Although many areas of the body often require multiple treatment procedures for optimal rejuvenation, combination therapy for specific areas is not yet well defined., Objective: To develop recommendations for the optimal combination and ideal sequence of botulinum toxin (BoNT), hyaluronic acid, calcium hydroxylapatite (CaHA), and microfocused ultrasound with visualization in nonfacial areas across all skin phototypes., Methods: Fifteen specialists convened under the guidance of a certified moderator. Consensus was defined as approval from 75% to 94% of all participants, whereas agreement of ≥95% denoted a strong consensus., Results: Recommendations have been provided for the neck, décolletage, and hands and include the timing and sequence of specific procedures when used concurrently or over several treatment sessions. Position statements are offered in lieu of consensus for the upper arms, abdomen, buttocks, and knees., Conclusion: Nonfacial rejuvenation often requires multiple procedures for optimal results in individuals with significant age-related changes. Further clinical studies are recommended to raise awareness of non-facial indications and provide clinicians with the best evidence for best treatment practices.
- Published
- 2016
- Full Text
- View/download PDF
30. Combining Microfocused Ultrasound With Botulinum Toxin and Temporary and Semi-Permanent Dermal Fillers: Safety and Current Use.
- Author
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Fabi SG, Goldman MP, Mills DC, Werschler WP, Green JB, Kaufman J, Weiss RA, and Hornfeldt CS
- Subjects
- Adult, Aged, Combined Modality Therapy adverse effects, Contusions etiology, Cosmetic Techniques adverse effects, Durapatite adverse effects, Face, Female, Herpes Simplex etiology, Humans, Hyaluronic Acid adverse effects, Male, Middle Aged, Neck, Purpura etiology, Retrospective Studies, Thorax, Botulinum Toxins, Type A adverse effects, Dermal Fillers adverse effects, High-Intensity Focused Ultrasound Ablation adverse effects, Neuromuscular Agents adverse effects, Skin Aging
- Abstract
Background: A microfocused ultrasound system with visualization (MFU-V) is currently indicated for use as a noninvasive dermatological aesthetic treatment to lift the eyebrows, lax submental and neck tissue, and improve lines and wrinkles of the décolleté., Objective: To determine the existence of any safety signals when combining MFU-V with botulinum toxin-A and/or semipermanent and temporary dermal fillers., Materials and Methods: A retrospective chart review was performed using subjects who received aesthetic treatments including incobotulinumtoxinA injection, cohesive polydensified matrix hyaluronic acid (CPM HA) dermal fillers, and calcium hydroxylapatite (CaHA) dermal fillers within 6 months of treatment with MFU-V in the same or different anatomic areas., Results: All subjects (N = 101; 96 female; 25-70 year old) received MFU-V, 18% received incobotulinumtoxinA injections, and 81% were treated with CPM HA and/or CaHA fillers. Seven adverse events (7%) were reported: bruising/purpura (n = 4), swelling (n = 1), paresthesia (n = 1), and herpes simplex virus (HSV) outbreak (n = 1). Only the HSV outbreak was considered to be related to combined treatments., Conclusion: Although limited by relatively few subjects, the results of the present study suggest that the safety profile of MFU-V combined with other aesthetic products is consistent with the safety profiles of the individual treatments.
- Published
- 2016
- Full Text
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31. Advancing the Care of Post-Acne Scarring: Expert Insights Into New Treatment Options.
- Author
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Werschler WP, Few JW, Jacob CI, Joseph JH, Spencer JM, and Taub AF
- Subjects
- Acne Vulgaris psychology, Cicatrix psychology, Humans, Treatment Outcome, Acne Vulgaris diagnosis, Acne Vulgaris therapy, Chemexfoliation trends, Cicatrix diagnosis, Cicatrix therapy, Dermatologic Agents administration & dosage
- Abstract
Most patients with acne have some degree of facial scarring even after their acne resolves, extending the period of psychosocial distress. Unfortunately, management of acne scars remains challenging. Many treatments for post-acne scarring including chemical peels, skin needling, laser resurfacing, surgical repair, subcision lifting, and punch elevation lifting, are limited by moderate and unpredictable results, significant morbidity, and substantial patient investments in time and money. The most recent addition to the armamentarium is tissue augmentation with soft tissue fillers, including a recently approved polymethylmethacrylate-collagen filler. Matching individual patient needs to the appropriate treatment is crucial. While many patients with acne scars have unrealistic expectations about treatment outcomes, open, honest, and realistic dialogue regarding their treatment options and concerns can facilitate realistic expectations. This article is based on a consensus discussion by the authors, who all have experience managing post-acne scarring, as well as the content of a series of live CME-accredited symposia in connection with major dermatology meetings., , J Drugs Dermatol. 2016;15(5):518-525.
- Published
- 2016
32. A Comprehensive Approach to Multimodal Facial Aesthetic Treatment: Injection Techniques and Treatment Characteristics From the HARMONY Study.
- Author
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Narurkar VA, Cohen JL, Dayan S, Kaminer MS, Rivkin A, Shamban A, Sykes JM, Teller CF, Weinkle SH, Werschler WP, Drinkwater A, Pucci ML, and Gallagher CJ
- Subjects
- Adult, Aged, Drug Therapy, Combination, Eyelashes, Face, Female, Humans, Hyaluronic Acid administration & dosage, Hypotrichosis drug therapy, Male, Middle Aged, Prospective Studies, Single-Blind Method, Antihypertensive Agents therapeutic use, Bimatoprost therapeutic use, Botulinum Toxins, Type A administration & dosage, Cosmetic Techniques psychology, Dermal Fillers administration & dosage, Neuromuscular Agents administration & dosage, Skin Aging
- Abstract
Background: The HARMONY study is the first clinical trial to assess the impact of a global approach to facial rejuvenation with several minimally invasive modalities, using patient-reported outcome measures., Objective: Provide details of this treatment approach and describe investigators' experiences and recommendations based on this study., Methods: This multicenter, 4-month study evaluated subject satisfaction with and psychological impact of combined treatment with VYC-20L (Juvéderm Voluma XC), HYC-24L (Juvéderm Ultra XC), HYC-24L+ (Juvéderm Ultra Plus XC), onabotulinumtoxinA (Botox), and bimatoprost 0.3% ophthalmic solution (Latisse). Treatment-naive adults with moderate-to-severe facial lines and folds and eyelash hypotrichosis received on-label, staged treatment with fillers. Bimatoprost was self-administered once daily for 17 weeks from day 1. OnabotulinumtoxinA was administered for glabellar lines, crow's feet lines, or both at month 3., Results: Overall, 100 subjects received bimatoprost for eyelash hypotrichosis, 96 received onabotulinumtoxinA for glabellar lines and/or crow's feet lines, and 96 received VYC-20L for midface volume deficit. From 17 to 96 subjects received HYC-24L and/or HYC-24L+ for nasolabial folds, oral commissures, marionette lines, perioral lines, or radial cheek lines. Injections of filler generally progressed from cranial to caudal, with midface injected first. Investigator-reported factors that may have contributed to the potential benefits of this approach include the critical role of the midface in facial aesthetics, use of lower volumes of filler in individual facial areas, and anesthetic effects., Conclusion: The investigators' perspectives and experience with the injection pattern, sequencing, volumes, and techniques may provide valuable guidance for a multimodal approach to facial aesthetic treatment.
- Published
- 2016
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- View/download PDF
33. Consensus Recommendations for Combined Aesthetic Interventions in the Face Using Botulinum Toxin, Fillers, and Energy-Based Devices.
- Author
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Carruthers J, Burgess C, Day D, Fabi SG, Goldie K, Kerscher M, Nikolis A, Pavicic T, Rho NK, Rzany B, Sattler G, Sattler S, Seo K, Werschler WP, and Carruthers A
- Subjects
- Combined Modality Therapy, Humans, Rejuvenation, Biocompatible Materials therapeutic use, Botulinum Toxins, Type A therapeutic use, Cosmetic Techniques, Dermal Fillers therapeutic use, Durapatite therapeutic use, Esthetics, Face, Hyaluronic Acid therapeutic use, Skin Aging, Ultrasonic Therapy methods, Viscosupplements therapeutic use
- Abstract
Background: The aging process is a complex interplay of intrinsic and extrinsic factors across multiple layers of the face. Accordingly, combining aesthetic interventions targeting different manifestations of aging often leads to better results than single modalities alone. However, no guidelines for a pan-facial approach using multiple interventions have been published to date., Objective: To develop consensus recommendations for the optimal combination and ideal sequence of botulinum toxin (BoNT), hyaluronic acid, calcium hydroxylapatite, and microfocused ultrasound with visualization (MFU-V) in persons of all Fitzpatrick skin types., Methods and Materials: Fifteen specialists convened under the guidance of a certified moderator. Consensus was defined as approval from 75% to 94% of all participants, whereas agreement of ≥95% denoted a strong consensus., Results: Optimal aesthetic treatment of the face begins with a thorough patient assessment and an individualized treatment plan. Spacing consecutive treatments 1 to 2 weeks apart allows for resolution of side effects and/or to assess results. For same-day treatments, BoNT and fillers may be performed together in either sequence, whereas MFU-V is recommended before injectable agents., Conclusion: Expert consensus supports a combination approach using multiple modalities in specific sequence for the safe and effective treatment of the aging face.
- Published
- 2016
- Full Text
- View/download PDF
34. Long-term Efficacy of Micro-focused Ultrasound with Visualization for Lifting and Tightening Lax Facial and Neck Skin Using a Customized Vectoring Treatment Method.
- Author
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Werschler WP and Werschler PS
- Abstract
Background: Micro-focused ultrasound with visualization has been cleared by the United States Food and Drug Administration to noninvasively lift the eyebrow, lift submental and neck tissue, and improve lines and wrinkles of the décolleté., Objective: The objective of this prospective, open-label pilot study was to evaluate the efficacy and safety of patient-specific, customized micro-focused ultrasound with visualization treatment with vertical vectoring to lift and tighten facial and neck tissue., Methods and Materials: Subjects 25 to 60 years of age (N=20) with areas of skin laxity on the face and neck were enrolled and treated. A dual depth treatment was administered using a vectored pattern. Subjects were evaluated after 90 days, 180 days, and one year., Results: Overall improvements in Subject Global Aesthetic Improvement Scale and Physician Global Aesthetic Improvement Scale scores were reported by 90 and 100 percent of subjects at 90 and 180 days, respectively, and 95 percent for both measures at one year. Six of 14 evaluable subjects were rated as improved by blinded assessment at one year. Self-reported improvements maintained for up to one year included less sagging (79%), fewer lines and wrinkles (58%), and smoother skin texture (47%)., Conclusion: Based on these results, treatment with micro-focused ultrasound with visualization with vertical vectoring demonstrated appreciable lifting and tightening of facial and neck tissue resulting in improved Global Aesthetic Improvement Scale scores and a high degree of patient satisfaction for up to one year. ClinicalTrials.gov Identifier: NCT01708512.
- Published
- 2016
35. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study.
- Author
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Koo J, Tyring S, Werschler WP, Bruce S, Olesen M, Villumsen J, and Bagel J
- Subjects
- Adult, Aerosols, Betamethasone administration & dosage, Calcitriol administration & dosage, Calcitriol therapeutic use, Dermatologic Agents therapeutic use, Drug Combinations, Female, Humans, Male, Middle Aged, Ointments, Single-Blind Method, Treatment Outcome, Betamethasone analogs & derivatives, Calcitriol analogs & derivatives, Dermatologic Agents administration & dosage, Psoriasis drug therapy
- Abstract
Background: An aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment., Objectives: To compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks., Methods: In this Phase II, multicenter, investigator-blind, 4-week trial, adult patients with psoriasis vulgaris were randomized to Cal/BD aerosol foam, Cal/BD ointment, aerosol foam vehicle or ointment vehicle (3:3:1:1). The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success (clear or almost clear with at least a two-step improvement) according to the physician's global assessment of disease severity., Results: In total, 376 patients were randomized. At week 4, significantly more patients using Cal/BD aerosol foam achieved treatment success (54.6% versus 43.0% [ointment]; p = 0.025); mean modified (excluding the head, which was not treated) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment (mean difference -0.6; p = 0.005). Rapid, continuous itch relief occurred with both active treatments. One adverse drug reaction was reported with Cal/BD aerosol foam (application site itch)., Conclusions: Cal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment.
- Published
- 2016
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36. Five-Year Safety and Satisfaction Study of PMMA-Collagen in the Correction of Nasolabial Folds.
- Author
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Cohen S, Dover J, Monheit G, Narins R, Sadick N, Werschler WP, Karnik J, and Smith SR
- Subjects
- Adult, Aged, Aged, 80 and over, Drug Combinations, Female, Follow-Up Studies, Humans, Injections, Intradermal, Male, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome, Young Adult, Collagen administration & dosage, Cosmetic Techniques, Nasolabial Fold, Patient Satisfaction, Polymethyl Methacrylate administration & dosage
- Abstract
Background: A polymethylmethacrylate-collagen filler is generally believed to give long-term benefits, but the risk of granuloma formation over time remains unclear., Objective: To determine the incidence of granuloma formation and response to treatment and assess the degree of patient satisfaction over 5 years., Materials and Methods: Adults seeking correction of nasolabial folds underwent up to 3 injection sessions over 2 months. Subjects were then queried regularly for the development of signs and symptoms of a granuloma. Any positive responses were evaluated, and lesions suspicious for granulomas were confirmed by biopsy. Granulomas were treated at the discretion of the investigator. Subjects also completed regular satisfaction questionnaires., Results: A total of 1,008 subjects were enrolled and 871 completed the full 5 years of the study. A biopsy-confirmed granuloma developed in 1.7% of subjects. Almost all granulomas responded to treatment. At study exit, 0.9% of subjects had an unresolved granuloma. Patient satisfaction remained high throughout the duration of the study., Conclusion: The incidence of granuloma formation with a polymethylmethacrylate-collagen dermal filler is low, and almost all lesions are manageable with simple therapeutic measures. Patient satisfaction remains durable over 5 years. Polymethylmethacrylate-collagen offers a well-characterized and very favorable risk/benefit profile.
- Published
- 2015
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37. Aesthetic Dermatologic Treatments: Consensus from the Experts.
- Author
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Werschler WP, Calkin JM, Laub DA, Mauricio T, Narurkar VA, and Rich P
- Published
- 2015
38. Dermatological Adverse Events Associated with Topical Brimonidine Gel 0.33% in Subjects with Erythema of Rosacea: A Retrospective Review of Clinical Studies.
- Author
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Holmes AD, Waite KA, Chen MC, Palaniswamy K, Wiser TH, Draelos ZD, Rafal ES, Werschler WP, and Harvey AE
- Abstract
Background: The topical α2 adrenergic receptor agonist brimonidine gel 0.33% is an effective and safe pharmacological treatment for the facial erythema of rosacea. However, adverse events of worsened redness have occasionally been reported with its use., Objective: A detailed analysis of adverse events is needed to accurately define worsening erythema and the adverse-events profile associated with brimonidine gel treatment., Methods and Measurements: A retrospective review of related dermatological adverse events occurring in subjects enrolled in the two pivotal four-week Phase 3 studies and the 52-week long-term safety study for brimonidine gel was conducted. Measurements included total adverse-event incidences; number of subjects experiencing adverse events; study discontinuation due to adverse events, severity, onset, episodic duration period; and correlation of adverse events to subject disposition, and rosacea profile., Results: Flushing and erythema were the most commonly reported adverse events, occurring in a total of 5.4 percent of subjects in the Phase 3 studies and in 15.4 percent in the long-term study. Most adverse events were mild or moderate in severity, transient, and intermittent. Adverse events occurred early in treatment, and duration was short-lived in the majority of cases. Adverse-event patterns were not remarkably altered with regard to subject disposition in the long-term study., Conclusion: Adverse events of worsening redness are not frequent, are transient in nature, and occur early in the course of treatment with brimonidine gel.
- Published
- 2015
39. Critical Considerations on Optimizing Topical Corticosteroid Therapy.
- Author
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Werschler WP, Herdener RS, Ross VE, and Zimmerman E
- Published
- 2015
40. Development and validation of a photographic scale for assessment of lip fullness.
- Author
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Werschler WP, Fagien S, Thomas J, Paradkar-Mitragotri D, Rotunda A, and Beddingfield FC 3rd
- Subjects
- Adult, Female, Humans, Male, Middle Aged, Observer Variation, Reproducibility of Results, Young Adult, Cosmetic Techniques, Lip anatomy & histology, Photography
- Abstract
Background: As lip augmentation becomes more popular, validated measures of lip fullness for quantification of outcomes are needed., Objective: Develop a scale for rating lip fullness and establish its reliability and sensitivity for assessing clinically meaningful differences., Methods: The initial Allergan Lip Fullness Scale (iLFS; a four-point photographic scale with verbal descriptions) was validated by eight physicians rating 55 live subjects during two rounds, conducted on one day. In addition, subjects performed self-evaluations. The revised Allergan Lip Fullness Scale (LFS), a five-point scale with a broader range of lip presentations, was validated by 21 clinicians in two online image rating sessions, ≥14 days apart, in which they used the LFS to rate overall, upper, and lower lip fullness of 144 3-dimensional (3D) images. Physician inter- and intra-rater agreement, subject intra-rater agreement (iLFS), and subject-physician agreement (iLFS) were evaluated. Additionally, during online rating session 1, raters ranked 38 pairs of 3D images, taken before and after lip augmentation, as "clinically different" or "not clinically different." The median LFS score difference for clinically different pairs was calculated to determine the clinically meaningful difference., Results: Clinician inter- and intra-rater agreement for the iLFS and LFS was substantial to almost perfect. Subject self-assessments (iLFS) had substantial intra-rater reliability and a high level of agreement with physician assessments. Median LFS score differences for overall, upper, and lower lip fullness were 1 (mean: 0.63-0.69) for "clinically different" and 0 (mean: 0.28-0.36) for "not clinically different" image pairs; thus, clinical significance of a 1-point difference in LFS score was established., Conclusions: The LFS is a reliable instrument for physician classification of lip fullness. A 1-point score difference can detect clinically meaningful differences in lip fullness., (© 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.)
- Published
- 2015
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41. A double-blind, randomized, multicenter, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic facial acne scars.
- Author
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Karnik J, Baumann L, Bruce S, Callender V, Cohen S, Grimes P, Joseph J, Shamban A, Spencer J, Tedaldi R, Werschler WP, and Smith SR
- Subjects
- Adult, Cicatrix etiology, Cicatrix pathology, Cosmetic Techniques, Double-Blind Method, Face pathology, Humans, Male, Microspheres, Middle Aged, Acne Vulgaris complications, Cicatrix therapy, Collagen administration & dosage, Polymethyl Methacrylate administration & dosage
- Abstract
Background: Acne scarring remains a stubborn clinical problem. Few treatments have been shown to be definitely effective for this problem. Polymethylmethacrylate (PMMA) microspheres in collagen (ArteFill, Suneva Medical Inc, Santa Barbara, CA) have shown long-term benefit for nasolabial fold treatment. A pilot study has shown benefit for PMMA-collagen in atrophic acne scarring., Objective: We sought to demonstrate the safety and effectiveness of PMMA-collagen for acne scarring in a controlled, blinded trial., Methods: Subjects with at least 4 moderate to severe rolling, atrophic scars randomly received PMMA-collagen or saline injections. Subjects underwent up to 2 injection sessions and were followed up for 6 months. Efficacy was assessed using a validated rating scale for each scar., Results: In all, 147 subjects underwent injections. Success was achieved by 64% of those treated with PMMA-collagen compared with 33% of control subjects (P = .0005). The treatment showed excellent safety with generally mild, reversible adverse events. No significant differences in efficacy or safety were noted between genders, for darker skin types, or in older age groups., Limitations: Subjects were followed up for only 6 months., Conclusion: PMMA-collagen demonstrates substantial effectiveness in the treatment of atrophic acne scars of the face while maintaining an excellent safety profile. Further follow-up should be undertaken to demonstrate longer-term benefit and safety., (Copyright © 2014 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.)
- Published
- 2014
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42. Efficacy and safety of ingenol mebutate 0.015% gel after cryosurgery of actinic keratosis: 12-month results.
- Author
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Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM, Larsson T, and Swanson N
- Subjects
- Adult, Aged, Aged, 80 and over, Combined Modality Therapy, Cryosurgery methods, Dermatologic Agents adverse effects, Diterpenes adverse effects, Double-Blind Method, Female, Follow-Up Studies, Gels, Humans, Keratosis, Actinic pathology, Keratosis, Actinic surgery, Male, Middle Aged, Dermatologic Agents therapeutic use, Diterpenes therapeutic use, Keratosis, Actinic drug therapy
- Abstract
Introduction: Recurrence rates of actinic keratosis (AK) lesions after cryosurgery are high, and this treatment does not address field cancerization. We investigated the efficacy and safety of field treatment of AKs with ingenol mebutate gel following cryosurgery., Methods: In this phase 3, randomized, double-blind, vehicle-controlled study (NCT01541553), patients ≥18 years with four to eight clinically typical, visible, discrete AKs within a contiguous 25-cm2 treatment area on the face or scalp underwent cryosurgery followed 3 weeks later by once-daily ingenol mebutate 0.015% or vehicle gel for 3 consecutive days. Endpoints included complete clearance at week 11 and safety and efficacy over 12 months., Results: In 329 randomized patients, complete clearance rates were greater with ingenol mebutate than vehicle (week 11: 60.5% vs 49.4%; P=.04; month 12: 30.5% vs 18.5%; P=.01). Fewer patients experienced the emergence of new lesions with ingenol mebutate than with vehicle (38.9% vs 51.9%; P =.02). At month 12, mean percentage reduction of AKs was higher with ingenol mebutate than with vehicle (68.2% vs 54.1%; P =.002). The probability of remaining free of lesions was sustained longer with ingenol mebutate compared with vehicle gel: 78% vs 68% at 6 months; 64% vs 57% at 9 months; 55% vs 40% at month 12, respectively. Ingenol mebutate 0.015% gel was well tolerated and no unexpected adverse events occurred; all adverse events resolved within 2 weeks of starting treatment., Conclusions: Field treatment with ingenol mebutate 0.015% gel following cryosurgery significantly enhanced clearance of baseline lesions, and was well tolerated. Furthermore, ingenol mebutate 0.015% gel following cryosurgery reduced development of new lesions in the treated field.
- Published
- 2014
43. Efficacy and safety of ingenol mebutate 0.015% gel 3 weeks after cryosurgery of actinic keratosis: 11-week results.
- Author
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Berman B, Goldenberg G, Hanke CW, Tyring SK, Werschler WP, Knudsen KM, Goncalves J, Larsson T, Skov T, and Swanson N
- Subjects
- Administration, Cutaneous, Aged, Combined Modality Therapy, Cryosurgery methods, Dermatologic Agents administration & dosage, Dermatologic Agents adverse effects, Diterpenes administration & dosage, Diterpenes adverse effects, Double-Blind Method, Face, Female, Follow-Up Studies, Gels, Humans, Keratosis, Actinic pathology, Keratosis, Actinic surgery, Male, Scalp, Treatment Outcome, Dermatologic Agents therapeutic use, Diterpenes therapeutic use, Keratosis, Actinic drug therapy
- Abstract
Introduction: Cryosurgery is the most common treatment for actinic keratosis (AK) in the United States. Efficacy with cryosurgery is variable, and is a modality for treating individual, visible lesions while failing to treat subclinical lesions., Methods: FIELD Study 1 (NCT01541553) is a phase 3, multicenter, randomized, double-blind study that evaluated the short- (11-week) and long- (12-month) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel, versus cryosurgery followed by vehicle., Results: Overall, 329 patients were randomized to ingenol mebutate 0.015% gel (n=167) or vehicle (n=162) 3 weeks after cryosurgery. Baseline characteristics were balanced across groups. At week 11, complete clearance rate (100%) in the treatment area was higher for ingenol mebutate gel compared with vehicle (60.5% vs 49.4%, respectively; P=.04). Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel (82.7% vs 75.6%). A general reduction from baseline lesion count was observed 3 weeks after cryosurgery. Treatment after cryosurgery was well tolerated., Conclusions: Short-term (11-week) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone.
- Published
- 2014
44. Who is the aesthetic consumer?
- Author
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Werschler WP
- Subjects
- Dermatology methods, Humans, United States, Cosmetic Techniques, Esthetics
- Published
- 2013
45. Safety and efficacy of a continuous-flow, injection-assisted device in delivery of dermal fillers.
- Author
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Lorenc ZP, Bruce S, and Werschler WP
- Subjects
- Adult, Aged, Equipment Design, Equipment Safety, Esthetics, Female, Humans, Injections, Subcutaneous, Male, Middle Aged, Nasolabial Fold, Patient Safety, Patient Satisfaction statistics & numerical data, Reference Values, Single-Blind Method, Skin Aging physiology, Statistics, Nonparametric, Treatment Outcome, Young Adult, Cosmetic Techniques instrumentation, Hyaluronic Acid administration & dosage, Skin Aging drug effects
- Abstract
Background: A device to assist in the delivery of dermal filler may achieve reductions in patient discomfort and adverse events, as well physician fatigue. It may also increase the accuracy of material placement., Objectives: The authors assess the safety and performance of the Artiste Assisted Injection System (Nordson Micromedics, St Paul, Minnesota) in normal therapeutic use compared with the standard manual administration of dermal fillers., Methods: At 3 study sites, a total of 52 patients (48 women and 4 men) received bilateral full-correction injections of dermal fillers into randomized nasolabial folds (NLF). Injection into 1 NLF was made via Artiste, and injection into the other NLF was made via manual delivery. Immediately posttreatment and through 29 days, physician investigators, patients, and blinded evaluators recorded treatment durations and volumes, evaluated designated posttreatment characteristics using questionnaires, and documented adverse events (AE) and differences in cosmetic effects., Results: Mean filler volume was 1.25 mL for the Artiste-treated NLF and 1.29 mL for manually treated NLF. One investigator used significantly less volume with Artiste than with manual injection (0.95 mL vs 1.12 mL; P = .001). Blinded evaluators rated Wrinkle Severity Rating Scale (WSRS) results as "identical" in 81% of patients. Investigator questionnaires showed a clear and statistically significant preference for Artiste over manual injection in all parameters (P < .001)., Conclusions: The Artiste device is a viable option for physicians seeking a continuous-flow, injection-assisted device for ease of treatment, better accuracy, and improved results.
- Published
- 2013
- Full Text
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46. A randomized, phase 2, dose-ranging study in the treatment of moderate to severe inflammatory facial acne vulgaris with doxycycline calcium.
- Author
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Leyden JJ, Bruce S, Lee CS, Ling M, Sheth PB, Stewart DM, Werschler WP, Gilbert RD, and Kircik L
- Subjects
- Acne Vulgaris pathology, Adolescent, Adult, Anti-Bacterial Agents administration & dosage, Anti-Bacterial Agents adverse effects, Child, Dose-Response Relationship, Drug, Double-Blind Method, Doxycycline administration & dosage, Doxycycline adverse effects, Face, Female, Humans, Inflammation pathology, Logistic Models, Male, Middle Aged, Severity of Illness Index, Young Adult, Acne Vulgaris drug therapy, Anti-Bacterial Agents therapeutic use, Doxycycline therapeutic use, Inflammation drug therapy
- Abstract
Background: Doxycycline calcium (WC2055) is a drug substance with a possible role in the treatment of acne. The objective of this study was to evaluate the safety and efficacy of three doses of doxycycline calcium tablets compared with placebo in the treatment of moderate to severe inflammatory facial acne vulgaris., Methods: This was a randomized, double-blind, phase 2 dose-ranging study in subjects with moderate to severe inflammatory acne aged 12 years to 45 years. Subjects were randomized to receive doxycycline calcium tablets 0.6, 1.2, or 2.4 mg/kg/day or placebo, and instructed to take their tablets once daily for 12 weeks, in the evening at least 1 hour before or 2 hours after mealtime. The primary efficacy variables were the dichotomized Investigator's Global Assessment score (success or failure) at week 12 (success defined as ≥ 2 score decrease from baseline) and the absolute change from baseline to week 12 in inflammatory lesion count., Results: A dose-response effect was seen with doxycycline calcium formulation in subjects with moderate to severe inflammatory acne. The highest dose-group (corresponding to approximately 2.4 mg/kg/day) showed a statistically significant difference from placebo. The dose-response effect was confirmed by logistic regression analysis for both treatment success and incidence of gastrointestinal adverse events. A limitation of this study is that safety and efficacy were only studied on moderate to severe inflammatory acne. Also, the study was not prospectively powered to show efficacy differences., Conclusion: Doxycycline calcium shows a dose-response effect in reducing inflammatory lesions in subjects with moderate to severe inflammatory acne.
- Published
- 2013
47. Oral lesions associated with injected hydroxyapatite cosmetic filler.
- Author
-
Werschler WP
- Subjects
- Female, Humans, Male, Cosmetic Techniques adverse effects, Durapatite adverse effects, Face, Granuloma, Foreign-Body chemically induced
- Published
- 2013
- Full Text
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48. Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles.
- Author
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Brandt FS, Cazzaniga A, Baumann L, Fagien S, Glazer S, Kenkel JM, Lowe NJ, Monheit GD, Narins RS, Rendon MI, Rohrich RJ, and Werschler WP
- Subjects
- Adult, Biocompatible Materials administration & dosage, Female, Follow-Up Studies, Humans, Injections, Polyesters, Single-Blind Method, Treatment Outcome, Collagen administration & dosage, Cosmetic Techniques, Lactic Acid administration & dosage, Polymers administration & dosage, Skin Aging
- Abstract
Background: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus., Objective: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE)., Methods: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report., Results: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p < .001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles., Conclusions: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.
- Published
- 2011
- Full Text
- View/download PDF
49. Subject global evaluation and subject satisfaction using injectable poly-L-lactic acid versus human collagen for the correction of nasolabial fold wrinkles.
- Author
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Brown SA, Rohrich RJ, Baumann L, Brandt FS, Fagien S, Glazer S, Kenkel JM, Lowe NJ, Monheit GD, Narins RS, Rendon MI, and Werschler WP
- Subjects
- Female, Humans, Injections, Lactic Acid adverse effects, Male, Patient Satisfaction, Polyesters, Polymers adverse effects, Biocompatible Materials administration & dosage, Collagen administration & dosage, Cosmetic Techniques, Lactic Acid administration & dosage, Polymers administration & dosage, Skin Aging
- Abstract
Background: This is a report of the secondary endpoints, Subject Global Evaluation (overall improvement) and Subject Satisfaction scores, from a study designed to examine the efficacy of injectable poly-L-lactic acid for the correction of nasolabial fold wrinkles over 25 months., Methods: A randomized, subject-blinded, parallel-group, multicenter clinical study was conducted to compare the effects of injectable poly-L-lactic acid with those of human collagen for the treatment of nasolabial fold wrinkles at 13 months following the last treatment. Injectable poly-L-lactic acid-treated subjects were followed for 25 months., Results: From month 3 through month 13 following the last treatment, injectable poly-L-lactic acid-treated subjects (n = 116) reported significantly higher Subject Global Evaluation scores compared with human collagen-treated subjects (n = 117; p < 0.001). Overall Subject Global Evaluation scores for injectable poly-L-lactic acid-treated subjects were 99 percent at week 3, 91 percent at month 13, and 81 percent at month 25 (all times following the last treatment). In contrast, for human collagen-treated subjects, overall Subject Global Evaluation scores declined by 84 percent, from 96 percent at week 3 to 15 percent at month 13. Subject Satisfaction scores were significantly different (p < 0.01) between treatment groups beginning week 3 and continuing through month 13. Overall Subject Satisfaction scores were maintained for over 80 percent of injectable poly-l-lactic acid-treated subjects (n = 106) at month 25 after the last treatment., Conclusions: Treatment of nasolabial fold wrinkles with injectable poly-l-lactic acid resulted in statistically significantly higher Subject Global Evaluation and Subject Satisfaction scores compared with human collagen at 13 months. Injectable poly-l-lactic acid-treated subjects maintained improvements for up to 25 months after treatment.
- Published
- 2011
- Full Text
- View/download PDF
50. Enhanced efficacy of a facial hydrating serum in subjects with normal or self-perceived dry skin.
- Author
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Werschler WP, Trookman NS, Rizer RL, Ho ET, and Mehta R
- Abstract
Objective: To evaluate the efficacy and tolerance of a facial hydrating serum when added to a moisturizer regimen compared to a moisturizer regimen alone., Design: Evaluator-blinded, single-center, clinical study with investigator assessments at Baseline and Week 2., Treatment: After washing with a facial cleanser in the morning and evening, subjects either applied the hydrating serum to their face followed by application of the moisturizer or applied only a moisturizer., Participants: Thirty-two women, aged 25 to 55 years with Fitzpatrick skin types I to V and normal or self-perceived dry skin completed the study. Seventeen subjects (Group 1) aged 25 to 51 years were randomly assigned to receive the facial hydrating serum in addition to a moisturizer regimen, whereas 15 subjects (Group 2) aged 34 to 55 years, were randomized to receive the moisturizer regimen alone., Measurements: Visual grading of the condition of the facial skin with regard to dryness, tactile roughness and softness, rating of irritation (subjective and objective), and digital photography. A self-assessment questionnaire was also employed to assess patient satisfaction., Results: Clinical assessments by the investigator showed statistically significant improvements (P<0.02) in facial skin parameters (reduction in dryness and increased skin softness) after two weeks of combined use of the hydrating serum and moisturizer compared to the group who used moisturizer alone. No adverse events were reported during the course of the study., Conclusion: The results from a two-week clinical study demonstrate that this facial hydrating serum was well tolerated and effective in improving facial dry skin parameters beyond that obtained with a moisturizer alone.
- Published
- 2011
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