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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.)

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.)

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.)

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.

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.

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.

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.

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.

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.

Actinic keratosis (AK), the initial lesion in a disease continuum that may progress to squamous cell carcinoma, often begins with ultraviolet B light-induced photo damage and increases in prevalence with age. Topical 5-fluorouracil (5-FU) for the treatment of widespread multiple AK lesions has cure rates of more than 90 percent. The associated skin irritation, however, may lead patients to prematurely discontinue treatment. To improve treatment efficacy and tolerability, 5-FU cream 0.5%, a novel Microsponge(®)-based formulation, was developed. In the elderly population, 5-FU cream 0.5% may be preferable because of its convenient (once daily) administration and its lower potential for irritation and systemic absorption, which may impact adherence to therapy and, thus, possibly increase cure rates.