The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

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 assessed by the investigator 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 of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target 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 was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.

CME: Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update.

Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15To receive a CME certificate of participation, you should: •Read the entire publication, including the CME information. •Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.Erratum published for this article here.

Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update

Since initial US Food and Drug Administration approval of botulinum toxin type A (BoNT-A) for aesthetic use in 2002, clinical evidence and experience with BoNT-A and understanding of facial anatomy have greatly increased, leading to rapid advances in treatment planning and implementation. BoNT-A use has expanded from the upper face to the midface, lower face, and neck, so that BoNT-A injection is the most common cosmetic procedure worldwide. Trends in facial aesthetics reflect growing patient diversity with respect to age, gender, and ethnicity. In October 2019, a multidisciplinary panel of 6 experts in minimally invasive injectable procedures in the specialties of dermatology and plastic surgery convened at the 2019 American Society for Dermatologic Surgery (ASDS) meeting in Chicago, IL. Their goal was to discuss recent advances in BoNT-A use in facial aesthetics, including implications of the introduction of new agents in light of an evolving patient population. J Drugs Dermatol. 2020;19(4 Suppl 1):s5-15 To receive a CME certificate of participation, you should: •Read the entire publication, including the CME information. •Register or log in at www.paradigmmc.com/822 to complete and submit the online posttest and evaluation. Following online completion of the posttest and evaluation, a certificate of participation will be available for download/printing immediately.

Erratum: Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update

Correction to the supplement, Re-examining the Optimal Use of Neuromodulators and the Changing Landscape: A Consensus Panel Update (J Drugs Dermatol. 2020; 19:4 Supp 1).

Safety and efficacy of hydrogen peroxide topical solution, 40% (w/w), in patients with seborrheic keratoses: Results from 2 identical, randomized, double-blind, placebo-controlled, phase 3 studies (A-101-SEBK-301/302).

BACKGROUND: Approved topical treatments for seborrheic keratoses (SKs) are an unmet need. OBJECTIVE: To evaluate the safety and efficacy of 40% hydrogen peroxide topical solution (HP40) versus vehicle for the treatment of SKs (A-101-SEBK). METHODS: A total of 937 patients with 4 SKs each (≥1 lesion each on the face and on the trunk and/or an extremity) were randomized 1:1 to HP40 or vehicle. At each visit, SKs were graded using the Physician's Lesion Assessment (PLA) scale (0, clear; 1, nearly clear; 2, ≤1 mm thick; and 3, >1 mm thick). After 1 treatment, SKs with a PLA score higher than 0 were re-treated 3 weeks later. RESULTS: At day 106, significantly more patients treated with HP40 than with vehicle achieved a PLA score of 0 on all 4 SKs (study 1, 4% vs 0%; study 2, 8% vs 0% [both P < .01]) and on 3 of 4 SKs (study 1, 13% vs 0%; study 2, 23% vs 0% [both P < .0001]). A higher mean per-patient percentage of SKs were clear (study 1, 25% vs 2%; study 2, 34% vs 1%) and clear or nearly clear (study 1, 47% vs 10%; study 2, 54% vs 5%) with HP40 than with vehicle. Local skin reactions were largely mild and resolved by day 106. LIMITATIONS: The optimal number of treatment sessions was not evaluated. CONCLUSION: Application of HP40 was well tolerated and effective in the removal of SKs.

Tox Outside the Box: Off-Label Aesthetic Uses of Botulinum Toxin.

*Proceedings from a recent cosmetic dermatology conference, Cosmetic Bootcamp, Aspen, CO.

Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis.

INTRODUCTION: A three-pronged approach to acne treatment combining an antibiotic, antimicrobial, and retinoid may be more efficacious than single/double treatments while potentially reducing antibiotic resistance. This study evaluated the efficacy and safety of the first fixed-dose, triple-combination topical acne product, clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) using pooled phase 3 data. METHODS: In two identical phase 3 (N = 183; N = 180), double-blind, 12-week studies, participants aged ≥ 9 years with moderate-to-severe acne were randomized 2:1 to receive once-daily CAB or vehicle gel. Endpoints included ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin (treatment success) and least-squares mean percent change from baseline in acne lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated. RESULTS: At week 12, 50.0% of participants achieved treatment success with CAB versus 22.6% with vehicle gel (P < 0.001). CAB resulted in > 70% reductions in inflammatory and noninflammatory lesions at week 12 (77.9% and 73.0%, respectively), which were significantly greater than vehicle (57.9% and 48.2%; P < 0.001, both). Most TEAEs were of mild-moderate severity, and < 3% of CAB-treated participants discontinued study/treatment because of AEs. Transient increases from baseline in scaling, erythema, itching, burning, and stinging were observed with CAB, but resolved back to or near baseline values by week 12. CONCLUSIONS: The innovative fixed-dose, triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear/almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04214639 and NCT04214652.

Making the right choices: attaining predictable aesthetic results with dermal fillers.

The types and number of dermal fillers have evolved, allowing clinicians to select the most appropriate agent for each specific use. Filler properties differ both between and among classes, so clinicians must have a thorough understanding of these properties and the best techniques to use to provide the most satisfactory outcomes. This article reviews and highlights the key properties of different types of fillers, technical aspects of their use, safety considerations and the importance of patient factors in treatment selection. Making the right treatment choices must involve all of these issues to optimize aesthetic outcomes and patient satisfaction. The authors illustrate how to make the best choices through a series of case examples using a variety of filler types. Although most fillers can provide acceptable outcomes when used appropriately, the hyaluronic acids have become the most frequently used products because of their physicochemical properties and clinical benefits.

The effect of lidocaine when mixed with large gel particle hyaluronic acid filler tolerability and longevity: a six-month trial.

OBJECTIVES: To determine if there is any effect on tolerance, adverse events or clinical outcome when lidocaine is added to large gel particle hyaluronic acid (LGP-HA). MATERIALS AND METHODS: Single-centered, double-blinded, randomized, with-in patient trial, comparing patient comfort when receiving LGP-HA injections versus injections of LGP-HA mixed with lidocaine hydrochloride 2% (LGP-HA + L). Results were determined through patient questionnaires, standardized Canfield photography and blinded physician assessors. Participants were followed for six months. RESULTS: Eighteen females were enrolled and completed the study. The average pain rating was significantly less when LGP-HA + L was administered as reported by participants and blinded investigators. Average rating of bruising and redness were less with LGP-HA + L, but not significant. After six months, 100 percent of participants and 100 percent of the primary and secondary blinded investigators reported no difference in clinical outcome or longevity between the different treatments. There was no difference in adverse events. CONCLUSION: This is the first trial to report a six-month follow-up in a split-face study comparing LGP-HA + L to LGP-HA alone. All participant and investigator reports found symmetry of the NLFs at six months, thus demonstrating that the addition of lidocaine to LGP-HA does not affect longevity. Administration of LGP-HA + L is associated with less patient discomfort than administration of LGP-HA alone.

Natural look in volume restoration.

Filling and volumizing injection procedures are currently widely used for facial augmentation and re-establishing a youthful appearance. Aesthetic physicians have advanced from the practice of treating single lines and wrinkles towards filling large facial areas to globally restore natural facial contours and meet patient demand for nonsurgical rejuvenation. This review describes the different categories of fillers and volumizers based on their duration of action and ability to create a natural looking effect; they can be broadly classified as temporary or long-lasting biodegradable agents, or permanent nonbiodegradable agents. Temporary fillers are effective to correct lines and wrinkles, but may not adequately meet the need for global facial rejuvenation and volume replacement in a long-term, cost-efficient manner. Permanent fillers for global restoration pose the issue of long-term safety, and may not be compatible with changes in facial architecture with continued aging. Longer lasting volumizers provide patients with a durable, effective option for the restoration of facial volume and the re-establishment of youthful facial contours. Temporary fillers and volumizers may also be used in combination to provide a wide source of options for the global restoration and rejuvenation of the face.

Nutraceuticals: A Review.

Skin aging is continuously influenced by various internal and external factors such as the biologic progression of cells, ultraviolet (UV) radiation, tobacco, nutritional deficiencies, and hormonal imbalances that lead to the degradation of skin cells. Through the degradation of skin cells, free radicals and inflammation weaken repair mechanisms and result in collagen and elastic fiber breakdown. The appearance of aging skin is highlighted by skin roughness, wrinkling, pigmentation change, telangiectasias, loss of elasticity, and decreased firmness, all of which are accelerated by these internal and external factors. Throughout the years, nutraceuticals have been studied to delay and fight against these internal and external factors, many of which are found in foods and byproducts consumed naturally. The aim of this review is to aid dermatologists in understanding the mechanism of action of popular nutraceuticals and their possible efficacy in antiaging and skin health.

Cosmeceutical peptides.

Peptide cosmeceuticals are one of the new, popular options to treat aging skin. There are three main categories of cosmeceutical peptides: signal peptides, neurotransmitter-affecting peptides and carrier peptides. Although their benefits currently may not be as rigorously tested as most FDA-regulated drugs, the evidence to support their use is growing. This article attempts to review the various current popular cosmeceutical peptides, the published studies on their theoretical effects, and their practical use in dermatology.

Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study.

BACKGROUND: A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers was approved by the FDA in June 2006. Compared with other HA fillers available in the United States at the time of writing, these new fillers have a higher concentration of HA, higher concentration of cross-linked HA, and a smooth consistency--which should promote long-lasting corrections and a smooth, natural look and feel postinjection. OBJECTIVE: The objective was to compare the effectiveness and safety of these smooth-gel HA dermal fillers with bovine collagen for nasolabial fold (NLF) correction. METHODS AND MATERIALS: A total of 439 subjects with moderate or severe NLFs received one of three types of smooth-gel HA dermal filler (in one NLF) and cross-linked bovine collagen (in the other NLF) and were evaluated for or=6 months. Up to 88% of subjects preferred the HA dermal fillers over bovine collagen. All fillers were similarly well tolerated. CONCLUSION: The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagen-which may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vast majority of subjects-which should promote patient satisfaction.

Dermatosis papulosis nigra: treatment options.

Dermatosis papulosis nigra (DPN) is a very prevalent skin condition among certain ethnic groups, especially African-Americans and Afro-Caribbeans. The histology is not significantly different from that of seborrheic keratosis. DPN does not pose any health dangers, but patients often seek removal due to aesthetic concerns since it occurs commonly on the face. When performing any elective procedure, it is important that great care is taken to prevent complications so as to not merely exchange one defect for another such as a scar or discoloration. This article will outline options for management of this common cosmetic problem.

Hyaluronic acid fillers in facial rejuvenation.

Nonsurgical procedures have become very popular for the rejuvenation of the aging face. Trends now are for less invasive procedures as well as for more preventative intervention to slow the damage from ultraviolet light and environmental factors, as well as from intrinsic aging. The goal of these procedures is to eliminate or delay the need for corrective surgery. The regular use of sunscreens; retinoids and improved cosmeceuticals; injectable neurotoxins; soft-tissue augmentation products; and minimally invasive laser, light, and radiofrequency treatments are decreasing and delaying need for invasive procedures. Injectable fillers entered mainstream cosmetic medicine with the development of bovine collagen injections in the 1980s. The availability of improved fillers that are less allergenic and longer lasting has resulted in a renaissance in filler techniques. No single filler has proven to be more popular than the category of hyaluronic acids (HA). This article will review the use of the hyaluronic acid fillers that are currently approved for use by the Federal Drug Administration in the United States and describe the significant differences between them to assist the practicing cosmetic physician in choosing and using this category of dermal filler.

The Unique Value of Core-only Continuing Medical Education.

The importance of training in minimally invasive cosmetic procedures is essential to insure safe outcomes for patients. Board certification in the appropriate specialty is one way to improve aesthetic outcomes. Meetings that consider appropriate residency training for admission can help achieve this goal.