Safety, Pharmacodynamic Response, and Treatment Satisfaction With OnabotulinumtoxinA 40 U, 60 U, and 80 U in Subjects With Moderate to Severe Dynamic Glabellar Lines.

BACKGROUND: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs. OBJECTIVES: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. METHODS: This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events. RESULTS: The modified intent-to-treat population (N = 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (P < 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; P < 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect. CONCLUSIONS: GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables.

A Prospective, Multicenter, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel-Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand.

BACKGROUND: Hand rejuvenation has become increasingly popular, but there are few reports published on the use of hyaluronic acid gels for correction of volume deficits in the dorsal hand. METHODS: This study evaluated the efficacy and safety of large-gel-particle hyaluronic acid with lidocaine, a 20-mg/ml hyaluronic acid gel with 0.3% lidocaine, compared to no treatment for the correction of volume deficits in the dorsal hand. This was a prospective, multicenter, split-hand study in 90 subjects who received treatment with product in one hand. The primary efficacy endpoint was based on a 1 point of improvement with treatment versus no treatment according to the Merz Hand Grading Scale at week 12. Other assessments included Central Independent Photographic Reviewers evaluations of hand photographs, Global Aesthetic Improvement Scale, subject satisfaction, and safety. RESULTS: The mean injection volume was 2.1 ml at the first treatment. Subjects demonstrated significantly higher response rates with treatment compared to no treatment at week 12 (85.9 percent versus 21.2 percent) and at weeks 16, 20, and 24 (p < 0.0001). Photographic Reviewers assessments showed consistently greater improvements in the treated hands compared with the untreated hands from week 12 to week 24. Most subjects and investigators (≥92.8 percent) reported improvements in Global Aesthetic Improvement Scale score across all time points with treatment. Treatment-related adverse events were reported in seven subjects (7.9 percent). Most of these were mild, and none were serious. CONCLUSION: Hyaluronic acid with lidocaine is safe, effective, and well tolerated for the correction of volume deficits in the dorsal hand. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

A Double-Blind, Placebo-Controlled, Phase 3b Study of ATX-101 for Reduction of Mild or Extreme Submental Fat.

BACKGROUND: ATX-101 (deoxycholic acid injection) is approved for reduction of moderate or severe submental fat (SMF). OBJECTIVE: To evaluate the efficacy and safety of ATX-101 in subjects with mild or extreme SMF. PATIENTS AND METHODS: Adults with mild or extreme SMF (based on clinician assessment) were randomized to receive ≤6 treatments with ATX-101 or placebo. Efficacy end points, evaluated at 12 weeks after last treatment, included percentage of subjects who achieved ≥1-grade improvement in SMF from baseline based on both clinician and patient assessment (composite CR-1/PR-1 response) as well as multiple subject-reported outcomes. Safety end points included change in skin laxity and incidence of adverse events. RESULTS: Overall, 61.3% of ATX-101-treated subjects versus 6.7% of placebo-treated subjects with mild SMF and 89.3% versus 13.3% of subjects, respectively, with extreme SMF achieved a composite CR-1/PR-1 response (p < .001 for both). ATX-101-treated subjects also reported higher levels of satisfaction and greater reductions in the psychological impact of SMF versus placebo-treated subjects regardless of baseline SMF severity. Skin laxity was unchanged or improved in most of the subjects. Adverse events were mainly mild/moderate, transient, and associated with the injection site. CONCLUSION: ATX-101 was efficacious and well tolerated for reduction of mild or extreme SMF.

Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study.

BACKGROUND: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVES: To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement. METHODS: In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment. RESULTS: LFS responder rates were 86.2%, 80.3%, and 65.3% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touch-up treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment. CONCLUSIONS: Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.

OnabotulinumtoxinA and Hyaluronic Acid in Facial Wrinkles and Folds: A Prospective, Open-Label Comparison.

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.

Relationship Between Midface Volume Deficits and the Appearance of Tear Troughs and Nasolabial Folds.

BACKGROUND: Understanding interrelationships among aging facial features is important in facial aesthetics as a global treatment approach becomes standard. OBJECTIVE: Examine empirical relationships between midface volume deficit and severity of tear troughs (TTs) and nasolabial folds (NLFs) in women and men of different racial/ethnic groups. METHODS: A web-based study was administered to health panel members (aged 18-75 years). Participants compared their midface volume, TTs, and NLFs against photonumeric scales depicting degrees of severity. Linear regressions were conducted to assess the relationship of midface volume on severity of TTs and NLFs, controlling for demographic factors. RESULTS: Of 4,086 participants (80.0% female), 3,553 had complete data. Increasing severity of midface volume deficit was associated with increasing severity of TTs and NLFs in both sexes (all p < .001). Race/ethnicity was associated with differences in severity in all 3 facial areas, although specific differences between races/ethnicities varied for women and men. Progression rates of severity differed between racial/ethnic groups. Correlations between midface volume deficit, TTs, and NLFs were positive and significant (all p < .001). CONCLUSION: Midface volume deficit was associated with severity of TT deformity and NLFs after controlling for age and other demographic variables.

Cosmetic Dermatology Training During Residency: Outcomes of a Resident-Reported Survey.

BACKGROUND: As the demand for cosmetic treatments increases, it is important for dermatology residents to be educated about and achieve proficiency in dermatologic cosmetic procedures. OBJECTIVE: To assess dermatology residents' educational exposure to cosmetic dermatology. MATERIALS AND METHODS: An anonymous 18-question survey was sent electronically to 1,266 dermatology residents requesting information about cosmetic dermatology training during residency. RESULTS: Two hundred sixty-eight residents responded to the survey (21% response rate). Most residents receive didactic instruction (94%) and hands-on training (91%) on cosmetic dermatology topics during residency. Survey participants in residency programs perceived as supportive of cosmetic dermatology training are more frequently provided lectures (70% vs 31%, p < .001) and procedural training (100% vs 69%, p < .001) in cosmetic dermatology as compared to residents in unsupportive programs. Eighty-nine percent of respondents reported hands-on training as the most effective method for developing proficiency in cosmetic procedures. CONCLUSION: Providing safe and competent patient care should serve as the impetus for expanding cosmetic dermatology education and training for residents.

Bending the Arc of the Trilobed Flap Through External Interlobe Angle Inequality.

BACKGROUND: The trilobed flap is a useful repair option for distal nasal defects. In certain cases, however, the placement of its quaternary defect may risk compression of the internal nasal valve or induction of ectropion. In this study, we propose a modified design of the trilobed flap, which uses unequal external interlobe angles. OBJECTIVE: To present the design principles and results of our modified trilobed flap for the reconstruction of difficult distal nasal Mohs defects. MATERIALS AND METHODS: Mohs defects of 26 patients were reconstructed (21 with long-term follow-up) using our modified trilobed flap over 1 year. Two independent masked raters graded postoperative photographs for alar symmetry and overall cosmesis. RESULTS: Median alar symmetry scores were excellent and overall cosmesis grades were between excellent and very good. CONCLUSION: The modified trilobed flap with unequal external angles offers an excellent option for reconstruction of Mohs defect of the distal nose that may not be well-suited for other repairs. Over 1 year, 21 modified trilobed repairs were performed with overall excellent outcomes.

Prevalence of Multifocal Primary Hyperhidrosis and Symptom Severity Over Time: Results of a Targeted Survey.

BACKGROUND: There is a paucity of data on the prevalence of multifocal primary hyperhidrosis and changes in hyperhidrosis severity over time. OBJECTIVE: The goal of this study was to better understand multifocal primary hyperhidrosis, prevalence and distribution of hyperhidrosis by focal site, age of onset of symptoms by focal area, and change in hyperhidrosis severity over time and with seasons. MATERIALS AND METHODS: The International Hyperhidrosis Society, through an unrestricted research grant from Revance Therapeutics, conducted an online survey of registered visitors to its Web site. Participants identified as having "excessive sweating" and opted to participate in the survey (23 questions) after an e-mail invitation. RESULTS: The survey data illustrate that multifocal primary hyperhidrosis is more common than previously believed and that multifocal hyperhidrosis is more common than singular focal hyperhidrosis (81% of patients reported 3 or more focal hyperhidrotic sites). The data also show that sweating symptom severity does not improve with age but stays the same or gets worse and is "bothersome" throughout the year. CONCLUSION: Recognition of the chronic and multifocal nature of primary hyperhidrosis is useful for treating hyperhidrosis patients long term and illustrates a need for treatments or treatment combinations that are effective for multiple body areas.

Proper Technique for Administration of ATX-101 (Deoxycholic Acid Injection): Insights From an Injection Practicum and Roundtable Discussion.

ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) is the first aesthetic injectable approved for reduction of submental fat. In February 2014, an injection practicum was conducted in the anatomy laboratory at the University of Texas Southwestern Medical Center to explore the proper injection technique for ATX-101 and the importance of its appropriate, safe anatomical placement within the submental area. Subsequent to the injection practicum, a structured roundtable discussion was conducted in which potential implications of the various injection protocols evaluated during the practicum were reviewed. Furthermore, the faculty had the opportunity to provide additional perspectives based on their clinical experience with facial injectables and ATX-101 specifically. In this article, the findings from the injection practicum and roundtable discussion are reported.

Anatomy of the Cervicomental Region: Insights From an Anatomy Laboratory and Roundtable Discussion.

In 2015, ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was approved as a first-in-class injectable drug for reduction of submental fat. Use of a pharmacologic/injectable therapy within the submental region requires a thorough understanding of cervicomental anatomy to ensure proper injection technique and safe administration. To this end, an anatomy laboratory was conducted to review key external landmarks and important internal anatomic structures that characterize the lower face and anterior neck. External landmarks that define the boundaries of the cervicomental and submental regions were identified including the inferior mandibular border, the anterior border of the sternocleidomastoid muscle, the antegonial notch, the submental crease, the thyroid notch, and the hyoid bone. Relevant internal anatomic structures, including preplatysmal submental fat (the target tissue for ATX-101) and the platysma muscle as well as critical neurovascular and glandular tissues were revealed by dissection. Of particular interest was the marginal mandibular branch of the facial nerve because it typically courses along the inferior mandibular border near the proposed treatment area for ATX-101.

Emerging Nonsurgical Treatments for Hyperhidrosis.

A variety of available treatment options are available for primary focal hyperhidrosis, and some can be combined to obtain maximum effective results. Most treatment options have only been studied in patients with axillary hyperhidrosis, and more studies are needed to develop therapies for other body regions. Several clinical trials are underway with promising preliminary results; however, there is still a large need for new therapies.

Periorbital Rejuvenation: Overview of Nonsurgical Treatment Options.

Numerous nonsurgical options for periorbital rejuvenation are available and can be used alone or as adjuncts to other nonsurgical and surgical options. Topicals, chemical peels, laser resurfacing, and dermabrasion therapy, along with neuromodulators and fillers, can be used to enhance the appearance of the periorbital region.

Duration of effect by injection volume and facial subregion for a volumizing hyaluronic acid filler in treating midface volume deficit.

BACKGROUND: Juvéderm Voluma XC (VYC-20L) is approved in the United States for correction of age-related volume loss in the midface region in adults. OBJECTIVE: To characterize the effects of VYC-20L in 3 midface subregions based on injection volumes. METHODS: In this single-blind controlled trial, subjects with midface volume deficit received VYC-20L in ≥1 of 3 facial subregions (zygomaticomalar, anteromedial cheek, and submalar), with touch-up treatment available 30 days later. Responders achieved ≥1-point improvement on the Mid-Face Volume Deficit Scale (MFVDS), analyzed by facial subregion and stratified by injection volume quartiles. Subject satisfaction and safety were assessed. RESULTS: The treatment arm comprised 235 subjects aged 35 to 65 years. Month 6 MFVDS responder rates were 75.5% for zygomaticomalar, 83.2% for anteromedial cheek, and 76.9% for submalar subregions. Higher responder rates were observed with increasing injection volume quartiles for each subregion. Similar median injection volumes (≈2.0 mL total) of VYC-20L provided correction durations of 15 to 24 months: 24 months for anteromedial cheek, 19 months for zygomaticomalar, and 15 months for submalar subregions. Subject satisfaction was high across injection volume quartiles. No unanticipated treatment-site adverse reactions occurred. CONCLUSION: VYC-20L is effective at restoring midface volume, with high subject satisfaction and an acceptable safety profile.

Local procedural approaches for axillary hyperhidrosis.

When medical options for axillary hyperhidrosis have failed, botulinum toxin is an effective, safe, and well-tolerated, although temporary, treatment option. For long-lasting or permanent efficacy, some patients turn to local procedures, such as superficial liposuction or manual curettage, or more invasive local surgery. Newer, minimally invasive treatments have become available, such as microwave energy thermolysis.

Managing hyperhidrosis: emerging therapies.

New therapies are being investigated to treat hyperhidrosis. Novel methods of delivering botulinum toxins and new topical therapies have been developed. Devices that can deliver heat to the area of the eccrine units can reduce sweating. Further studies need to be performed.

A randomized, blinded clinical evaluation of a novel microwave device for treating axillary hyperhidrosis: the dermatologic reduction in underarm perspiration study.

BACKGROUND: Duration of effect and effectiveness limit current options for treating axillary hyperhidrosis. A new microwave procedure for treatment of axillary hyperhidrosis has been tested. STUDY DESIGN/MATERIALS AND METHODS: Adults with primary axillary hyperhidrosis were enrolled in a randomized, sham-controlled, blinded study. Subjects were required to have a Hyperhidrosis Disease Severity Scale (HDSS) score of 3 or 4 and baseline sweat production greater than 50 mg/5 min. Procedures were administered using a proprietary microwave energy device that isolates and heats target tissue. Responders were defined as subjects reporting a HDSS score of 1 or 2. Subjects were followed for 6 months (sham group) or 12 months (active group). RESULTS: Thirty days after treatment, the active group had a responder rate of 89% (72/81), and the sham group had a responder rate of 54% (21/39) (P < .001). Treatment efficacy was stable from 3 months (74%) to 12 months (69%), when follow-up ended. Adverse events were generally mild, and all but one resolved over time. CONCLUSIONS: The procedure demonstrated statistically significant, long-term efficacy in sweat reduction. As with any new procedure, findings from this first investigational device study identified optimization strategies for the future.

An open-label trial of the efficacy of 15% aluminum chloride in 2% salicylic acid gel base in the treatment of moderate-to-severe primary axillary hyperhidrosis.

Primary focal hyperhidrosis (HH) is a chronic disorder of excessive sweating. A single-center, open-label study was performed to determine the efficacy and safety of 15% aluminum chloride (AC) in 2% salicylic acid gel base (SAGB) Hydrosal in adults with moderate-to-severe primary axillary HH. Thirty subjects were given 15% AC in 2% SAGB to apply to their bilateral axillae nightly for the first week, then twice-weekly application as tolerated. The primary objective was change in mean Hyperhidrosis Disease Severity Score (HDSS) score from baseline to week 4. Participants who achieved an HDSS score < 2 were designated as "responders." Mean change in HDSS from baseline to week 4 was 1.32 (p = 0.0001). At week 4, 21 of 29 (72%) were responders, and at week 12, 18 of 25 (72%) were responders. Based on these results, 15% AC in 2% SAGB may be an effective, high-strength AC topical therapy for treatment of patients with moderate-to-severe axillary HH.