Search

Background: Medical aesthetic procedures for facial rejuvenation with laser and energy-based devices (EBDs) are rapidly increasing. The following cases highlight real-life experience using a multi-modality system with various handpieces that combine intense pulsed light (IPL), laser hair removal (808 diode), high-intensity focused ultrasound (HIFU), radiofrequency microneedling (RFM), and thermal radiofrequency (RF) for antiaging and rejuvenation treatment. Laser and RFM treatments may improve skin conditions by inducing cutaneous changes that remodel the skin matrix., Methods: Six physicians who treat patients for skin rejuvenation reported on clinical cases from their practice using a multi-modality system with various handpieces., Results: During the meeting, the advisors discussed 15 cases and agreed to select seven patients with different ages and skin phototypes receiving various treatments for photodamage of the face, neck, and décolleté. The advisors discussed why they selected the case, previous treatment, type of treatment, results, and clinical pearls., Conclusion: Sharing best practices in medical aesthetics using combination treatments on a single multi-modality energy-based device such as laser and MRF for facial, neck, and chest skin may support healthcare providers treating patients for skin rejuvenation to improve clinical outcomes., (© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.)

Background: AbobotulinumtoxinA has become well established as a treatment option for moderate to severe glabellar lines since its first aesthetic approval in 2009., Objective: Pivotal trials leading to regulatory approval showed that abobotulinumtoxinA treatment was associated with high responder rates when defined as achievement of none or mild glabellar lines (0 or 1 on the glabellar line severity scale) and a duration of action of up to 5 months. More recently, the goals for treatment of glabellar lines have shifted toward not only achieving a decrease in glabellar line severity but also ensuring that patients are satisfied with their experience., Materials and Methods: Patients seek an improvement in the appearance of their glabellar lines while maintaining a "natural look," fast onset of effect, and long duration of response., Results: Trial designs have evolved to meet these new targets, including expanding the definition of responders to those having at least 1-grade improvement in the glabellar line severity scale score from baseline coupled with the use of subject satisfaction and psychological well-being questionnaires., Conclusion: The findings demonstrate that abobotulinumtoxinA remains a well-tolerated and consistently effective treatment option associated with a rapid onset of effect, duration of efficacy lasting up to 6 months, and high, long-lasting levels of patient satisfaction., (Copyright © 2024 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: All skin tones need to be protected from the damaging effects of solar radiation. Although mineral sunscreens offer protection, they can have a thick, greasy feel and leave a white cast, particularly on darker skin tones. Tints offset white cast and provide visible light protection; however, patients may prefer a sheer option. Therefore, a multifunctional, sheer, 100% mineral sunscreen moisturizer (MSM) with broad-spectrum SPF 50 was developed to have positive aesthetics and deliver anti-aging and skin health benefits to all skin tones.  Methods: An IRB-approved, 12-week, open-label clinical study was conducted to investigate the efficacy and tolerability of the MSM. Thirty-nine (39) females aged 35 to 60 years with moderate-severe overall facial photodamage and representing all Fitzpatrick skin types (FST) were recruited. Participants applied the MSM to the face and neck in the morning and reapplied per US Food and Drug Administration requirements. Efficacy and tolerability grading, photography, ultrasound imaging, corneometer measurements, and questionnaires were completed at baseline and weeks 4, 8, and 12.  Results: Statistically significant progressive improvements were demonstrated from baseline to week 12. At week 12, 23.4% and 26.5% mean improvements in overall photodamage were seen for FST I-III and FST IV-VI, respectively. Favorable tolerability was shown for both the face and neck. Photography corroborated clinical grading, and ultrasound imaging indicated a trend in skin density improvement. The MSM was well-perceived.  Conclusion: The MSM is an efficacious and well-tolerated product for patients of all skin tones who desire a sheer, 100% mineral sunscreen moisturizer with anti-aging and skin health benefits. J Drugs Dermatol. 2024;23(7):538-544.  doi:10.36849/JDD.8082.

Background: Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem., Objective: To evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials., Materials and Methods: Baseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale. An integrated analysis using pooled BLESS data was conducted on these secondary end points., Results: Among enrolled and treated subjects ( N = 1,272), 85.5% had moderate to severe psychological impact at baseline. LetibotulinumtoxinA subjects experienced significant improvements compared with placebo on all measures. Mean improvement to Week 4 for the Modified Skindex-16 GL-QoL Scale overall score was -33.84 for letibotulinumtoxinA subjects compared with -1.37 for placebo subjects ( p < .001). Attenuation of psychological burden was highly correlated with improvement in glabellar line severity ( p < .0001)., Conclusion: LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome., (Copyright © 2024 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL)., Objective: To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL., Materials and Methods: A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction., Results: OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days., Conclusion: A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.)

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.)

Background: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum., Objectives: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines., Methods: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study., Results: The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug-related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Eight patients (1.4%) experienced study drug-related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed., Conclusions: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes., (© 2021 The Aesthetic Society.)

Background: Real-world re-treatment intervals for botulinum toxins vary, but most subjects receive treatment less frequently than the manufacturer-recommended minimum intervals. In subjects receiving treatment with AbobotulinumtoxinA (ABO) less frequently, high levels of satisfaction and psychosocial improvements in well-being, self-confidence, and quality of life are observed., Objective: To evaluate subject satisfaction with a twice yearly re-treatment schedule., Methods and Materials: This open-label, multicenter, interventional study evaluated subject satisfaction following injections of ABO 50 U in the glabellar lines at baseline and 6 months. The primary end point was subject satisfaction at 12 months. Secondary endpoints included subject satisfaction, FACE-Q scales, and glabellar line severity scale (GLSS)., Results: Ninety-five percent of the 120 subjects were "highly satisfied" or "satisfied" with their treatment outcomes at 12 months. FACE-Q total scores suggested that subjects were less bothered by glabellar lines and felt better about their facial appearance with each treatment versus baseline. Approximately half of subjects had ≥1-grade improvement from baseline in GLSS at 12 months. Median onset of effect was 2 days., Conclusion: The majority of subjects (95%) were satisfied with ABO treatment every 6 months; results were supported by high subject satisfaction, long duration, rapid onset, natural-looking results, and overall psychological wellness and safety., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.)

Background: Pivotal studies of approved botulinum toxin type A (BoNTA) formulations for treatment of glabellar lines have mostly included treatment-naive participants, and the impact of prior BoNTA treatment on efficacy and safety is not well documented., Objective: To evaluate whether prior BoNTA treatment affects efficacy, duration of response, and tolerability for treatment of glabellar lines., Methods: Adults with moderate or severe glabellar lines treated with DaxibotulinumtoxinA for Injection (DAXI) or placebo from the randomized, double-blind SAKURA 1/2 trials and the open-label SAKURA 3 safety study were analyzed by prior BoNTA treatment status. Efficacy was evaluated using investigator and participant assessments., Results: In this analysis, 609 participants (52.2% BoNTA-experienced) from the SAKURA 1/2 trials and 2,380 (38.0% BoNTA-experienced) from the SAKURA 3 study were evaluated. Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups. The incidence of adverse events was also comparable regardless of prior BoNTA treatment status., Conclusion: Efficacy and tolerability were similar with DAXI and placebo regardless of prior BoNTA treatment. Assuming an appropriate washout is observed, future BoNTA trials should enroll both treatment-experienced and treatment-naive participants to reflect clinical practice., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.)

Background: DaxibotulinumtoxinA for Injection (DAXI) is botulinum toxin Type A formulated with a novel peptide excipient. Two pivotal, single-treatment, placebo-controlled trials demonstrated efficacy and safety for moderate or severe glabellar lines., Objective: To further evaluate DAXI in a large, open-label, repeat-treatment study., Methods: Subjects (n = 2,691) were enrolled from the preceding pivotal trials or de novo and received 40U DAXI. Those who received repeat treatments could be retreated when they returned to baseline on the Investigator Global Assessment-Frown Wrinkle Severity (IGA-FWS) and Patient FWS (PFWS) scales at/after 12 weeks and up to 36 weeks after treatment., Results: High (>96%) response rates (none or mild severity) on the IGA-FWS scale were seen after each of the 3 treatments, with peak response between Weeks 2 to 4. At Week 24, ≥32% had a response of none or mild severity. Peak response rates of ≥92% were observed at Weeks 2 to 4 on the PFWS scale. The median duration for return to moderate or severe severity was 24 weeks. The safety profile was favorable and consistent with previous trials., Conclusion: DaxibotulinumtoxinA for Injection efficacy was highly consistent across treatment cycles. These results confirm the previously observed efficacy rates and duration of response., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society for Dermatologic Surgery, Inc.)

BACKGROUND: Aging is a complex process due to the interplay of intrinsic factors (such as genetics and hormones) and extrinsic factors (including ultraviolet radiation and pollution). A significant cause of intrinsic aging in women is the loss of estrogen as a result of the onset of menopause. OBJECTIVE: A single site experience trial to assess the efficacy of Emepelle (Biopelle, Ferndale Pharma Group, Ferndale, MI), a skin care regimen containing Methyl Estradiolpropanoate (MEP)®, for the treatment of Estrogen Deficient Skin (EDS). The secondary objective was to assess patient tolerability and satisfaction. METHODS: Fourteen female subjects aged 53-68 years who were amenorrheic for 1-10 years (mean, 5 years), with at least a Grade II in Wrinkling (fine to moderate-depth wrinkles, moderate number of lines) and score of at least 5 (of 9; moderate-to-severe) in elastosis on the clinician-assessed Fitzpatrick-Goldman Classification of Wrinkling and Elastosis Scale, and a 3 or greater on the Investigator Facial Skin Hydration Scale, were included in the study. The subjects were instructed to apply the product Emepelle Serum in the morning, and the product Emepelle Night Cream in the evening to the entire freshly washed and dried face. Follow up visits were performed at 8 weeks, 14 weeks, and 20 weeks to evaluate efficacy and safety. Canfield Visia Complexion Analysis and standard photography was performed at baseline and at each follow up visit. RESULTS: On a 0-4 Facial Hydration Scale, 100% of study participants by week 20 showed at least one-grade improvement and 93% saw two grades or more improvement in hydration. 100% of study participants showed aesthetic improvements per investigator-assessed Global Aesthetic Improvement Scale (GAIS) at week 14. By week 20, 93% of study participants responded that the combination of Emepelle Serum and Night Cream regimen helped improve wrinkles, texture, and color, and 86% of study participants responded that Emepelle helped improve sun-damage, thickness, and integrity. In the Quality of Life questionnaire, 86% responded that Emepelle helped alleviate some or all of the skin issues they developed since entering menopause. Investigator clinical assessment scored patients with a 53% improvement in texture, 21% improvement in keratoses, and 15% improvement in laxity on the Alexiades-Armenakas Comprehensive Grading Scale for Assessment of Skin Aging and Photodamage by the end of the study at week 20. CONCLUSIONS: Patients in the study indicated satisfaction with the formulations of Emepelle Serum and Night Cream. Younger patients showed significant improvement by about 8 weeks. For patients who have been in menopause longer, significant improvement was seen by week 20, suggesting MEP’s potential ability to reactivate dormant estrogen receptors. J Drugs Dermatol. 2019;18(12):1226-1230.

Background: Two licensed reconstitution volumes may be used to achieve the recommended abobotulinumtoxinA (ABO) dose for glabellar line correction., Objective: Comparison of efficacy, safety, and subject satisfaction concerning treatment of moderate to severe glabellar lines with 2 different ABO reconstitution volumes., Materials and Methods: Phase IV, prospective, randomized, multicenter, subject- and evaluator-blinded study: 60 subjects received 1 ABO (50 units) treatment, administered as a 1.5- or 2.5-mL reconstitution. Primary objective was Day 30 improvements (≥1-point) in glabellar line severity. Onset of effect, duration, subject satisfaction, and treatment-related adverse events (AEs) were assessed., Results: At Day 30, 90.0% and 86.7% of subjects achieved ≥1-point improvements with 1.5- and 2.5-mL reconstitutions, respectively. Median time to onset of effect was 48 hours after treatment. At 24 hours, 26.7% achieved ≥1-point improvements with the 2.5-mL reconstitution versus 6.7% with the 1.5-mL reconstitution. Maximum response was at Day 14, and >40% maintained efficacy through Day 120 in each group. High subject satisfaction was sustained throughout observation. Most AEs were mild. No serious AEs were reported., Conclusion: Both ABO reconstitutions were well tolerated and effective in correcting glabellar lines with no significant differences concerning efficacy or duration of effect. No serious AEs were reported.

Background: OnabotulinumtoxinA and hyaluronic acid are effective in improving moderate to severe facial wrinkles and folds, with treatment selection traditionally based upon facial area., Objectives: This prospective, multicenter, open-label, crossover study evaluated physician-rated efficacy and patient-rated outcomes following moderate to severe facial wrinkles and folds treatment with onabotulinumtoxinA and hyaluronic acid., Methods: 152 subjects (25-65 years) were randomized (1:1) to a treatment-sequence of onabotulinumtoxinA/hyaluronic acid or hyaluronic acid/onabotulinumtoxinA, with initial treatment administered on day 1 and 6 additional visits: week 2 (touch-up); week 4 (crossover); week 6 (touch-up); and weeks 8, 12, and 24 (follow-up)., Results: Between 92% and 100% of subjects in each treatment-sequence group exhibited at least some improvement from baseline at each study visit in the Physician Aesthetic Improvement Scale and the Objective Observer and Patient Global Assessments of Improvement, with no significant between-sequence differences. Subjects reported looking 3 to 6 years younger at each visit, with significant improvements in glabellar, lateral canthal, and horizontal forehead lines, and nasolabial folds. Treatments were well tolerated., Conclusions: OnabotulinumtoxinA and hyaluronic acid provide clinically meaningful improvements as rated by physicians, objective observers, and subjects, with clinical synergy in aesthetic effects and duration of response regardless of treatment administration order in subjects seeking improvement in moderate to severe facial wrinkles and folds.

Background and Objective: Misperceptions have persisted regarding scanning full-field erbium laser that have caused it to be overshadowed by fractional ablative resurfacing. This can lead to sub-optimally treating the periocular and perioral skin. Our report describes the utility of a combined approach of fractional ablative CO2 with full-field erbium ablation for full face rejuvenation. Each laser has a role in creating the optimal outcomes for advanced photoaging in the fewest treatments., Methods: A patient with severe photodamage and etched-in lines underwent full face fractional ablative CO2 (CO2RE, Syneron Candela) and full-field ablative perioral and periocular erbium laser (Contour TRL, Sciton Inc.). The pre-procedure consultations included evaluation of the severity of the photodamage and etched-in lines, as well as discussion of patient goals and appropriate treatment options. Photos of similar patients and post-treatment recovery were reviewed. Fully ablative lasers are generally avoided in Fitzpatrick skin type IV-VI. Prior to treatment, full face nerve blocks and topical anesthesia was provided. Full facial fractional ablative CO2 laser was then applied in one orthoganol pass to the whole face. This was followed by treating the infraorbital and perioral skin with four passes of full field erbium laser. Visualized residual lines were focally treated. Marked improvement was seen in a single treatment session., Results: Standardized digital imaging revealed dramatic improvement in skin texture and etched lines., Conclusion: For appropriately selected patients, combination fractional ablative CO2 and full-field ablative erbium resurfacing for facial rejuvenation is safe, efficacious and merits consideration. J Drugs Dermatol. 2018;17(7):796-799.

BotulinumtoxinA (BoNT-A) is now widely established for the main approved indication of reducing glabellar lines, and is also widely used off-label to improve the appearance of wrinkles and lines in other parts of the face. The number of aesthetic procedures continues to increase as the patient population becomes more diverse, in particular with increasing numbers of people of color and men. Further developments in treatment may continue to expand the audience for BoNT-A by making procedures more comfortable and by delivering a more natural, less static appearance. These may be achieved through use of combinations of BoNT-A with other aesthetic procedures, tailoring the dose of toxin to the patient's muscle mass or by using novel injection and application techniques. Beyond amelioration of facial lines, encouraging results have been seen with the use of BoNT-A to improve the appearance of hypertrophic and keloid scars and even to prevent them. Studies have been conducted with scars in various parts of the body and further research is ongoing. Dermatological and other medical uses for BoNT-A are also active areas of research. Injections of BoNT-A have been shown to reduce signs and symptoms of acne, rosacea, and psoriasis, to reduce neuromuscular pain, and to bring about significant improvements in a number of rare diseases that are caused or exacerbated by hyperhidrosis. This paper reviews these new uses for BoNT-A, looking at the rationale for their use and discussing the results of published case studies and clinical trials. These areas have shown great promise to date, but more and larger clinical studies will be required before these treatments become a clinical reality. To this end details are also provided of clinical trials currently listed in the main clinical trials database to highlight research areas of particular interest., (© 2017 The American Society for Aesthetic Plastic Surgery, Inc.)

A systematic review of the published literature (from January 2000 to January 2016) to ascertain the safety of, and patient satisfaction with, the aesthetic use of abobotulinumtoxinA was conducted. In addition to the licensed indications, other special populations were considered for discussion. The potential impact of neutralizing antibodies and systemic toxicity were also addressed. A total of 364 papers were screened and 86 were found to be relevant to the population, intervention(s), and outcomes stipulated in the protocol. The safety and patient satisfaction data from these publications are discussed in this review., (© 2017 The American Society for Aesthetic Plastic Surgery, Inc.)

In this multi-center pilot study, the safety pro le of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for safety in the treatment of the aging neck and face. A newly designed insulated microneedle system delivers a signi cant coagulative thermal injury into the dermis while sparing the epidermis from RF injury. Thirty- ve healthy subjects from seven aesthetic practices were evaluated, and data from each were incorporated in this case report. The subjects received a single treatment using settings that delivered the highest RF energies suggested from the new recommended protocols. The depth of thermal delivery was adjusted before each pass and all subjects received a minimum of two to three passes to the treated areas. Before and after photographs along with adverse effects were recorded. This case report demonstrates the ability to deliver significant RF thermal injury to several layers of the dermis with insulated microneedles safely with little injury to the epidermis and minimum downtime.

Hand rejuvenation is an increasingly requested procedure in dermatology. Dorsal hand augmentation with soft tissue filler is one aspect of hand rejuvenation. Calcium hydroxyapatite is FDA approved for this purpose, while at the present time other filler products are utilized but are considered off-label for dorsal hand augmentation. This article reviews the relevant anatomy, the general and filler-specific techniques commonly employed, and potential complications that may arise. , , J Drugs Dermatol. 2016;15(7):809-815.

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.

Fine lines and wrinkles, loss of volume, texture changes, and solar lentigines around the mouth are the result of both extrinsic and intrinsic factors, and are common concerns seen in cosmetic practice. Perioral rejuvenation can be addressed using a variety of noninvasive means including botulinum toxin, fillers, and laser resurfacing. In clinical practice, a multifaceted treatment plan utilizing a variety of noninvasive means to address the multiple tissue changes is often undertaken. Combining botulinum toxin with fillers or laser resurfacing has previously been shown to produce more desirable and longer lasting results. Here we report the results of using a sequential approach with all three modalities.

Background: The Merz Hand Grading Scale (MHGS) is a 5-point scale used to grade appearance of the dorsum of the hand. The MHGS has been previously validated for assessment of photographed hands but not for live assessment., Objective: The purpose of this randomized, blinded study was to validate the MHGS for live assessment of the hands in the clinical setting., Methods: Three physician raters completed a scale qualification program that included MHGS training, ratings of standardized hand photographs, and statistical analysis for reliability. Eighty-four subjects (28 males, 30% Fitzpatrick skin Types IV-VI, mean age of 42 years), randomized to 2 live assessment sessions for independent and blinded observation of dorsa of their right hands, completed the study., Results: Overall MHGS intrarater weighted Kappa value was 0.74 (0.68-0.79 [CI 95%]). First- and second-time hand-rating agreement scores ranged from 64% to 75%. Interrater weighed Kappa values ranged from 0.59 to 0.71, representing between-rater paired results of each combination of raters., Conclusion: High-weighted Kappa values and agreements demonstrate that consistency at different time points can be achieved individually and by different raters for live assessments. The MHGS is a suitable instrument for live assessment in the clinical setting.

Background and Objective: Since the introduction of the scanning full-field erbium laser, misconceptions regarding ablative erbium resurfacing have resulted in its being largely overshadowed by ablative fractional resurfacing. This case report illustrates the appropriateness of full-field erbium ablation for perioral resurfacing., Methods: A patient with profoundly severe perioral photodamage etched-in lines underwent full-field ablative perioral resurfacing with an erbium laser (Contour TRL, Sciton Inc., Palo Alto, CA) that allows separate control of ablation and coagulation. The pre-procedure consultations included evaluation of the severity of etched-in lines, and discussion of patient goals, expectations, and appropriate treatment options, as well as a review of patient photos and post-treatment care required. The author generally avoids full-field erbium ablation in patients with Fitzpatrick type IV and above. For each of 2 treatment sessions (separated by approximately 4 months), the patient received (12 cc plain 2% lidodaine) sulcus blocks before undergoing 4 passes with the erbium laser at 150 μ ablation, no coagulation, and then some very focal 30 μ ablation to areas of residual lines still visualized through the pinpoint bleeding. Similarly, full-field ablative resurfacing can be very reliable for significant wrinkles and creping in the lower eyelid skin--where often a single treatment of 80 μ ablation, 50 μ coagulation can lead to a nice improvement., Results: Standardized digital imaging revealed significant improvement in deeply etched rhytides without significant adverse events., Conclusion: For appropriately selected patients requiring perioral (or periorbital) rejuvenation, full-field ablative erbium resurfacing is safe, efficacious and merits consideration.

Background: Botulinum neurotoxin type A trials in aesthetic indications have used differing efficacy parameters and responder definitions., Objective: To analyze the treatment efficacy and duration of incobotulinumtoxinA for glabellar frown lines using pooled data from 2 large, Phase 3, placebo-controlled trials, and end points similar to those used in previous botulinum neurotoxin type A studies., Materials and Methods: IncobotulinumtoxinA and placebo groups comprised 366 and 181 subjects, respectively. The efficacy of a single 20-U treatment of incobotulinumtoxinA or placebo was evaluated by investigator-assessed and subject-assessed responder rates (≥ 1-point improvement from baseline), mean score, and mean change from the baseline glabellar frown line severity score., Results: At all follow-up visits, responder rates and mean change from the baseline score (investigator-assessed and subject-assessed) were significantly greater for incobotulinumtoxinA versus placebo (p < .0001). The maximum investigator-assessed responder rate (93.1%) was achieved at Day 30 after treatment, when the mean improvement on the 4-point facial wrinkle scale peaked at 1.88. Treatment effect declined over time but the investigator-assessed responder rate was 45.7% at the end of the study., Conclusion: Superiority of incobotulinumtoxinA over placebo for treating glabellar frown lines was confirmed. IncobotulinumtoxinA achieved a maximum responder rate of 93.1% and a long duration of treatment effect: 45.7% of subjects showed efficacy at 120 days.

Background: Because abobotulinumtoxinA treatment for glabellar lines must be repeated regularly to prevent recurrence, understanding the safety and effectiveness of long-term, repeated administration of abobotulinumtoxinA is important., Objective: To report the long-term safety and efficacy of abobotulinumtoxinA in patients with moderate to severe glabellar lines., Methods and Materials: AbobotulinumtoxinA was administered to 1,415 patients in multiple cycles over 24 months as a fixed dose of 50 U or as a dose based on muscle mass and sex (women: 50-70 U; men: 60-80 U). Adverse events were assessed after each visit on days 7, 14, and 30 and monthly thereafter; monitoring continued every 3 months for a total safety monitoring duration of 36 months or less., Results: Nine hundred ninety-one (70%) patients reported treatment-emergent adverse effects (TEAEs); most events were mild (70%) or moderate (20%) in severity. The rate of TEAEs did not increase over 24 months of repeated treatment (mean 5.6 cycles; range 1-9). Treatment-related eyelid ptosis followed 53 of 7,938 (0.7%) treatments, all of which resolved spontaneously., Conclusions: Multiple cycles of abobotulinumtoxinA treatment over 24 months were well tolerated and effective for the correction of glabellar lines, with no evidence of cumulative safety problems., (© 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.)

Background: A prospective, randomized, double-blind, multicenter, Phase III trial of incobotulinumtoxinA using new Food and Drug Administration endpoints., Objective: To investigate the efficacy and safety of a single dose of incobotulinumtoxinA for the treatment of glabellar frown lines., Materials and Methods: Two hundred seventy-one subjects with moderate to severe glabellar frown lines at maximum frown-as assessed by an investigator according to the facial wrinkle scale (FWS)-were randomized 2:1 to receive one treatment of 20 U of incobotulinumtoxinA or placebo, respectively, and assessed over 120 days. The primary efficacy variable was a composite endpoint consisting of patients who were 2-point or more responders at maximum frown on Day 30 according to the investigator's rating on the FWS, and 2-point or more responders at maximum frown on Day 30 according to the patient's assessment on a 4-point scale. Safety analyses were performed throughout the study., Results: IncobotulinumtoxinA was statistically significantly more efficacious than placebo using a new rigorous composite endpoint (p < .0001)., Conclusion: A single dose of 20 U of incobotulinumtoxinA is superior to placebo in the treatment of glabellar frown lines at Day 30 and is well-tolerated., (© 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.)

Background: Growth factors (GFs) are chemical messengers that regulate specific cellular activities such as cell proliferation and formation of the extracellular matrix. GFs may be derived from a variety of sources, including animals., Objective: Evaluate the safety and efficacy of a topical antiphotoaging product containing secretions of the snail Cryptomphalus aspersa (SCA) for the improvement of facial rhytides., Materials and Methods: This was a 2-center, double-blind, randomized, 14-week study in which 25 patients with moderate to severe facial photodamage were treated with an emulsion (with 8% SCA) and liquid serum (with 40% SCA) on one side of the face and placebo on the contralateral side for 12 weeks. Silicone skin impressions of periocular rhytides were performed at baseline and after 12 weeks of treatment. Patient and physician assessments were also performed at 8, 12, and 14 weeks., Results: Periocular rhytides on the active ingredient side showed significant improvement after 12 weeks (P=.03) and improved texture to a greater degree than placebo at 8 and 12 weeks, as well as 2 weeks after discontinuing the product (14 weeks)., Conclusion: Daily application of topical products containing SCA proved effective and well tolerated for improvement in coarse periocular rhytides and fine facial rhytides. Subjects noted a significant degree of improvement in fines lines at the 8-week time point on the SCA-treated side (P≤.05) but did not report a significant difference in the quality of their skin.

Background: Fractional ablative and nonablative lasers are useful tools for facial rejuvenation; however, ablative lasers require a period of downtime during reepthelialization. A procedure that combines both ablative and nonablative lasers may deliver good cosmetic results and reduce downtime or other side effects of treatment., Objective: The purpose of this study was to compare a combined fractional ablative and nonablative laser procedure to ablative-only procedures for facial rejuvenation., Methods: A total of 8 subjects in 2 study groups received a single, split-face, facial rejuvenation procedure in this study. In group A, we compared a combined procedure using a fractional nonablative 1,440-nm neodymium-doped yttrium aluminum garnet (YAG) laser and a fractional ablative 2,940-nm erbium (Er)-doped YAG laser on one side of the face, and a combined confluent/fractional ablative Er:YAG laser on the other. In group B, we compared the same 1,440/2,940 treatment as group A on one side of the face, and a fractional ablative CO2 laser on the other. Subjects were followed for 3 months to assess side effects and improvement in Fitzpatrick Wrinkle Score and pigmentation., Results: Improvement in wrinkles and pigment were seen with all techniques in both groups, and results were equivalent. Areas treated with combined fractional nonablative and ablative technique demonstrated fewer immediate side effects., Conclusion: Facial rejuvenation using a combination treatment of fractional ablative 2,940 and nonablative 1,440 lasers provides improvement in wrinkles and pigment similar to conservative purely ablative approaches. These purely ablative approaches include the Er:YAG laser used in a sequential confluent fractional manner, or fractional CO2 laser alone. Reduced side effects make the combined procedure an attractive option for facial rejuvenation.

Background: Hyaluronic acid (HA) is the most frequently injected filler for soft tissue augmentation in the United States., Objective: To systematically review published evidence for aesthetic use of small- and large-gel-particle HA., Methods and Materials: Clinical data on anatomic area, level of evidence, patient population, trial design, endpoints, efficacy, and safety were extracted from PubMed., Results: Fifty-three primary clinical reports were analyzed. The highest-quality efficacy evidence was for the nasolabial folds (NLFs), with 10 randomized, blind, split-face, comparative trials. Several randomized, blind trials supported treatment of the glabella, lips, and hands. Lower-level evidence (from studies with nonrandomized, open-label, or retrospective designs) was recorded for the nasojugal folds (tear troughs), upper eyelids, nose, infraorbital hollows, oral commissures, marionette lines, perioral rhytides, temples, and cheeks. Common adverse events (AEs) across anatomic areas were pain, bruising, swelling, and redness. Serious AEs were uncommon (8 events in 8 patients of 4,605 total patients) and were considered to be unrelated (7 events) or probably unrelated (1 event) to treatment., Conclusion: The efficacy and safety of small- and large-gel-particle HA are well established for NLFs; evidence for the glabella, lips, and hands is more limited. Preliminary reports in other anatomic regions suggest efficacy without major complications., (© 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.)

Background: Few dosing data on onabotulinumtoxinA to treat hyperdynamic perioral lines (POLs) are available. Studying onabotulinumtoxinA in controlled settings is beneficial to treating a hyperfunctional orbicularis oris., Objective: To compare the dose-response relationship of two doses of onabotulinumtoxinA in hyperdynamic POLs., Methods: Female subjects (N = 60) received injections of onabotulinumtoxinA at four sites totaling 7.5 U or 12.0 U. Subjects returned at weeks 2, 4, 8, 12, 16, and 20. POL severity and total lip satisfaction (TLS) were assessed at all visits., Results: Investigator-assessed POL severity was reduced through week 20 for 12.0 U (p < .01). POL reduction for 7.5 U persisted until week 16 (p < .05). Responder rates did not differ until week 12 (12.0 U, 77%; 7.5 U, 36%; p = .003). Subject-assessed TLS was improved (p < .05) at all time points for both groups except at week 20 (12.0 U; p = .06). Most adverse events (AEs) were mild to moderate in severity and typical for onabotulinumtoxinA treatment in the lips, and the incidence was dose-dependent., Conclusion: OnabotulinumtoxinA provides significant reductions in POL severity and high levels of subject satisfaction. Lack of dose response and fewer AEs suggest that treatment of hyperdynamic POLs with 7.5 U appears adequate for up to 16 weeks., (© 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.)

The availability of dermal fillers for multiple cosmetic indications has led to a dramatic increase in their application. Although fillers are generally regarded as safe tools for soft tissue augmentation, complications can occur. Therefore, to describe and review the complications associated with the currently-available dermal filling agents, the authors conducted a literature review in peer-reviewed journals and present the reported complication rates. They also describe current strategies to avoid, diagnose, and manage complications if they do occur.

The market for non-permanent fillers has grown dramatically over the past years. Even though hyaluronic acid fillers and collagen are forgiving, complications, albeit rare, still occur. Up to now, a necessary element of any dermatologic surgeons' office is a hyaluronidase in case one of these complications should occur. However, these agents will only work on hyaluronic acid fillers leaving any problem with collagen products to be resolved by other means. Later this year the first collagenase could be approved for usage in specific medical conditions; at that time it will, perhaps, complement its hyaluronidase counterpart.

Background: A new formulation of botulinum neurotoxin type A (BoNTA-ABO; Dysport [abobotulinumtoxinA]; Medicis Aesthetics, Scottsdale, AZ) was recently approved by the US Food and Drug Administration for the treatment of moderate to severe glabellar lines., Objective: To assess the long-term safety of repeat administrations of BoNTA-ABO for the treatment of glabellar lines, including variable dosing. This report summarizes an interim analysis that does not address the efficacy profile., Methods: Over 24 months, 1415 subjects underwent open-label retreatment with BoNTA-ABO. Patients were retreated with 50 units or a variable dose of 50, 60, 70, or 80 units based on gender and muscle mass. Dose was divided among five points in the glabellar region. Retreatments were performed if at least 85 days had elapsed between treatments and the glabellar line severity score was reassessed as moderate or severe. Patients were followed up at seven, 14, and 30 days postinjection, then monthly. Endpoints were adverse events (AE)., Results: Of 1415 patients, 932 (66%) experienced at least one AE. The rate of treatment-emergent AE (TEAE) was similar in both the fixed- and variable-dose groups. Most TEAE were rated mild (70%) or moderate (20%). The majority (87%; 3361/3861) of all TEAE instances were considered not related or unlikely to be related to study treatment. The overall incidence of TEAE and related events remained relatively constant or decreased over repeat cycles., Conclusions: Multiple cycles with fixed or variable dosing of BoNTA-ABO are well tolerated. There was no evidence of cumulative safety issues because the incidence of AE remained relatively constant or decreased over repeated treatment cycles.

Background: A new formulation of botulinum toxin type A (BoNT-A) (Dysport) has recently been approved in the United States for the treatment of glabellar lines., Objective: We sought to evaluate the long-term safety of repeated administrations of this BoNT-A formulation., Methods: In all, 768 individuals (1500 planned) from phase III clinical trials received as many as 6 repeated treatments of open-label BoNT-A (50 U) over 17 months, with a minimum of 85 days between treatments. Participants received a telephone call at day 7 postinjection to check for adverse event (AE), with clinical evaluations on days 14 and 30, and monthly until retreatment, study completion, or early termination. Safety end points were AEs, changes in vital signs, and assessment of serum-neutralizing antibodies to BoNT-A., Results: Of the 285 participants reporting at least one treatment-emergent AE at the interim analysis cutoff, only 74 (26%) reported at least one possibly or probably related event after 2259 treatments with BoNT-A. The incidence of treatment-emergent AEs around the injection sites and eyes was low (< or = 3%). Ten participants (1%) experienced 10 instances of ptosis. No participants developed neutralizing antibodies to BoNT-A or clinically significant changes in vital signs., Limitations: This is an interim analysis of a larger multicenter extension study., Conclusions: Multiple treatments with BoNT-A (50 U) over 17 months were well tolerated.

Chemical peeling is a popular, relatively inexpensive, and generally safe method to refresh and rejuvenate skin. This review focuses on superficial chemical peels and their use in routine clinical practice. A wide variety of peels are available, utilizing various actives and concentrations, including a recently introduced salicylic acid derivative, beta-lipohydroxy acid, which has properties that may expand the clinical use of peels. Superficial peels can be used to enhance treatment within a variety of conditions, including acne, melasma, dyschromias, photodamage and actinic keratoses. In addition, peels can be combined with other in-office procedures to optimize outcomes and enhance patient satisfaction, and allow clinicians to tailor the treatment to individual patient's needs. Successful outcomes are based on a thorough understanding and application of correct chemical peel procedures, including history-taking, pretreatment, preparation, peel selection, patient communication and maintenance regimens.Used properly, the superficial chemical peel has the potential to fill an important therapeutic need in the treatment armamentarium of dermatologists and plastic surgeons.

Evidence of the signs associated with skin aging often first appears in the periorbital area and includes wrinkles, eyelid bags, circles around the eye, or a "tired" look. This multicenter study aimed to investigate a novel eye cream containing a proprietary mixture of human growth factors and cytokines in combination with caffeine, bisabolol, glycyrrhetinic acid, and sodium hyaluronate for periorbital rejuvenation. The study, which was completed by 37 female subjects between 36 to 65 years of age, revealed that clinical signs for wrinkles, lower eyelid bags or sagging, dark circles, and skin texture show significant improvement (average 14%-28%) after 6 weeks of twice-daily application. These clinical improvements were confirmed by a subject questionnaire. The subjects further reported that their tired look significantly improved by 32% in average. All subjects tolerated the eye cream well and liked the way it felt. The cream's efficacy, excellent tolerability in the delicate periorbital skin area, and pleasant sensory properties explain why a large majority (78%) would continue regular use.

Recent additions to the soft tissue augmentation armamentarium have greatly increased the dermatologic surgeon's choices in optimizing facial contouring and the treatment of acne scars. In this article, we review the science of fillers and look at the future of dermal fillers.