Integrating skin color assessments into clinical practice and research: A review of current approaches.

Skin color classification can have importance in skin health, pigmentary disorders, and oncologic condition assessments. It is also critical for evaluating disease course and response to a variety of therapeutic interventions and aids in accurate classification of participants in clinical research studies. A panel of dermatologists conducted a literature review to assess the strengths and limitations of existing classification scales, as well as to compare their preferences and utilities. We identified 17 skin classification systems utilized in dermatologic settings. These systems include a range of parameters such as UV light reactivity, race, ethnicity, and degree of pigmentation. The Fitzpatrick skin type classification is most widely used and validated. However it has numerous limitations including its conflation with race, ethnicity, and skin color. There is a lack of validation data available for the remaining scales. There are significant deficiencies in current skin classification instruments. Consensus-based initiatives to drive the development of validated and reliable tools are critically needed.

Comparing the Efficacy and Tolerability of Moderate to Severe Hyperpigmentation and Skin Unevenness.

Dyschromia is the result of irregular facial pigmentation. These cutaneous manifestations can have a significant impact on the quality of life of those affected, especially among females and skin of color. In this randomized, double-blinded, two-cell, single-center, 16-week clinical study, all subjects had moderate to severe (scores 4-9 on the modified Griffiths Scale) hyperpigmentation and skin unevenness of the face such that approximately 20% of subjects had post-inflammatory hyperpigmentation (PIH), 40% had overall mottled hyperpigmentation, and 40% had superficial melasma (Superficial Melasma was determined by Wood's Lamp Assessment). Study participants received either Product A (proprietary new formulation - Cysteamine HSA) or Product B (current marketed product - Cyspera®) and used the test product either in the morning or at night, beginning with every other day application, and then advanced to every day, or as tolerated. The results revealed that both Product A (Cysteamine HSA) and Product B (Cyspera®) had statistically significant improvement in facial hyperpigmentation and skin unevenness, however, Product A (Cysteamine HSA) had better tolerability results for scaling, peeling, burning, stinging, erythema, and dryness, indicating that Product A (Cysteamine HSA) outperformed Product B (Cyspera®). J Drugs Dermatol. 2024;23(1):1260-1265.     doi:10.36849/JDD.7584.

Sunscreen Use for Photoprotection in Skin of Color: A Literature Review.

BACKGROUND: To understand the prevalence and types of publications addressing darker skin types within the existing evidence base for sunscreen use.  Evidence Review: PubMed was searched from 1988, the time point at which the first skin of color (SOC) article was identified, through December 2022 using PubMed's Medical Subject Headings terms and keyword searches in title and abstract, with and without terms for SOC and ethnicity. Identified articles were reviewed for relevance, de-duplicated, and categorized; results are summarized. FINDINGS: Of the 5927 articles on sunscreen overall, only 314 (5.3%) articles addressed SOC, with the majority published since 2007 and representing only 4% to 7% of total publications annually except in 2022 when the proportion of SOC articles was 23.5%. Of the articles on SOC, many reported sunscreen knowledge and patient behaviors (29%), but very few reported clinical trials (5%). The 3 conditions most often discussed were melasma, post-inflammatory hyperpigmentation, and dyschromia. South Asian ethnicities (India, Pakistan, Bangladesh) had the highest representation within the literature, followed by Hispanics. CONCLUSIONS AND RELEVANCE: Although it was assumed there would be fewer papers discussing the use of sunscreen in darker skin types, the scale of the disparity revealed by this study is stark. The increase in a number of articles in 2022 suggests an increasing focus on SOC, but further discussion of the issues presented here will help the SOC community address gaps in the evidence base and better inform discussions on sunscreen and photoprotection between clinicians and patients.J Drugs Dermatol. 2024;23(7):575-577.  doi:10.36849/JDD.8250.

Benefit of Topical Combination Therapy for Acne: Analyzing Effect Size Using Number Needed to Treat.

BACKGROUND: Topical acne trials often are confounded by high vehicle response rates and differing outcome measures, making it difficult to compare treatments. Number needed to treat (NNT) can be a simple, clinically meaningful way to indirectly compare treatment options without head-to-head data. NNT is the number of patients who need to be treated with an intervention to observe one additional patient successfully achieving a desired outcome versus vehicle/placebo. While treatment attributes such as adverse events may not be captured, lower NNT is a good indicator of a more effective treatment. METHODS: Following a search of combination topical treatments for acne vulgaris, all treatments that reported pivotal trial efficacy data consistent with the 2018 FDA definition of success were included in NNT analyses.  Results: Of 13 treatments, 7 reported 12-week treatment success rates in 11 phase 3 trials, with similar baseline demographics/disease severity. Treatment success ranged from 26.8% with tretinoin 0.1%/benzoyl peroxide (BPO) 3% cream to 50% with triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel. NNTs for the triple-combination gel were 4 and 5 (from 2 pivotal trials). Adapalene 0.3%/BPO 2.5% gel had an NNT of 5. Tretinoin/BPO had the largest range between trials, with NNTs of 4 and 9. The other 4 treatments had NNTs ranging from 6 to 8. CONCLUSION: A comparison of combination topical acne treatment trial data, using the same treatment outcome and similar patient populations, resulted in triple-combination clindamycin phosphate/adapalene/BPO gel and adapalene/BPO gel having the most favorable NNTs.J Drugs Dermatol. 2024;23(2):42-49.  doi:10.36849/JDD.7927.

Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne in Adult and Pediatric Participants.

BACKGROUND: Topical clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel (CAB) is the first fixed-dose triple-combination approved for the treatment of acne. This post hoc analysis investigated the efficacy and safety of CAB in pediatric (<18 years) and adult (greater than or equal to 18 years) participants. METHODS: In two multicenter, double-blind, phase 3 studies (NCT04214639 and NCT04214652), participants greater than or equal to 9 years of age with moderate-to-severe acne were randomized (2:1) to 12 weeks of once-daily treatment with CAB or vehicle gel. Pooled data were analyzed for pediatric and adult subpopulations. Assessments included treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score and a score of 0 [clear] or 1 [almost clear], inflammatory/noninflammatory lesion counts, Acne-Specific Quality of Life (Acne-QoL) questionnaire, treatment-emergent adverse events (TEAEs), and cutaneous safety/tolerability. RESULTS: At week 12, treatment success rates for both pediatric and adult participants were significantly greater with CAB (52.7%; 45.9%) than with vehicle (24.0%; 23.5%; P<0.01, both). CAB-treated participants in both subgroups experienced greater reductions from baseline versus vehicle in inflammatory (pediatric: 78.6% vs 50.4%; adult: 76.6% vs 62.8%; P<0.001, both) and noninflammatory lesions (pediatric: 73.8% vs 41.1%; adult: 70.7% vs 52.2%; P<0.001, both). Acne-QoL improvements from baseline to week 12 were significantly greater with CAB than with a vehicle. Most TEAEs were of mild-to-moderate severity; no age-related trends for safety/tolerability were observed.  Conclusions: CAB gel demonstrated comparable efficacy, quality of life improvements, and safety in pediatric and adult participants with moderate-to-severe acne. As the first fixed-dose, triple-combination topical formulation, CAB represents an important new treatment option for patients with acne. J Drugs Dermatol. 2024;23(6):394-402.     doi:10.36849/JDD.8357.

Efficacy, Convenience, and Safety of Calcipotriene-Betamethasone Dipropionate Cream in Skin of Color Patients With Plaque Psoriasis.

BACKGROUND: Psoriasis affects diverse racial and ethnic groups. In July 2021, the US Food and Drug Administration approved calcipotriene/betamethasone dipropionate (CAL/BDP) 0.005%/0.065% cream to treat plaque psoriasis in adults. The efficacy and safety of CAL/BDP in patients with skin of color (SOC) who have psoriasis is not well characterized. METHOD: A post hoc analysis of phase 3 clinical trial data (NCT03308799) was conducted to assess the efficacy, convenience, and safety of CAL/BDP cream versus CAL/BDP topical solution and vehicle cream in people with Fitzpatrick skin types IV to VI.   Results: This study included 784 participants, 280 (35.7%) of whom had Fitzpatrick skin types IV to VI. Patients treated with CAL/BDP cream had greater disease improvement, treatment convenience scores, and overall satisfaction than those treated with CAL/BDP topical solution in the subgroup with skin types IV to VI and the total study population.  Adverse event rates were similar between the subgroup with skin types IV to VI and the total study population for all treatment arms.  Conclusion: Psoriasis is associated with a greater physical and psychosocial impact in patients with SOC. While many effective topical therapies exist, it may be helpful to conduct separate analyses of patients with SOC to assess the efficacy and safety of treatment in this population. This sub-analysis of phase 3 clinical trial data supports the efficacy and safety of CAL/BDP cream in the treatment of plaque psoriasis in patients with SOC. CAL/BDP cream also had greater convenience, formula acceptability, and overall satisfaction in both the subgroup with SOC and the total trial population, which may improve adherence to topical therapy and treatment outcomes for people with SOC who have psoriasis. Kontzias CL, Curcio A, Gorodokin B, et al. Efficacy, convenience, and safety of calcipotriene-betamethasone dipropionate cream in skin of color patients with plaque psoriasis. J Drugs Dermatol. 2023;22(7):668-672. doi:10.36849/JDD.7497.

Racial/Ethnic Variations in Acne: Implications for Treatment and Skin Care Recommendations for Acne Patients With Skin of Color.

BACKGROUND: Acne vulgaris is among the most common dermatologic diagnoses observed, including skin color (SOC) populations. This project sought to help clarify the existing published data and provide consensus statements on acne presentation, prevention, treatment, and maintenance in SOC populations to help improve patient outcomes. METHODS: Six SOC dermatologists convened for a virtual meeting and used a modified Delphi process to address: 1) Are there racial/ethnic differences in the clinical presentation and sequela of acne? 2) Are there racial/ethnic differences in the therapeutic endpoint of acne treatment and patient expectations? 3) Is there a need for specialized approaches to therapeutic options and skincare in acne patients with SOC? The results of a literature review and the outcome of discussions, coupled with the panel's expert opinion and experience, are intended for health care providers caring for acne patients and clinician-researchers. RESULTS: Racial/ethnic differences in the clinical presentation, sequelae, and desired treatment outcomes for acne have been reported. Notwithstanding limitations in the number, size, and methodologies of studies to date, the available data suggest that strategies that improve outcomes in acne patients with SOC include: Early initiation and maintenance of treatment regimens and careful consideration of tolerability of active ingredients, vehicles, and dosing. Using pH-balanced, non-irritating cleansers and non-comedogenic ceramides containing moisturizers help minimize irritation or dryness. CONCLUSIONS: There a need for specialized approaches to therapeutic options and skincare in acne patients with SOC. OTC skincare products are recommended before and during prescription therapy and as part of a maintenance regimen. J Drugs Dermatol. 2021;20(7):716-725. doi:10.36849/JDD.6169 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Safety and Efficacy of Clobetasol Propionate 0.05% Emollient Foam for the Treatment of Central Centrifugal Cicatricial Alopecia.

Background: There is currently an unmet need for the treatment of women with central centrifugal cicatricial alopecia (CCCA). Objective: To evaluate the safety and efficacy of Clobetasol propionate 0.05% emollient foam for the treatment of women with CCCA. Methods: Adult women of African descent that presented with clinical evidence of early CCCA were enrolled (N=30). Clobetasol propionate 0.05% emollient foam was applied daily in an open-label fashion. Safety and efficacy assessments were performed at weeks 2, 6, 12, and 14. Results: Subjects achieved substantial improvements in pruritus, pain, tenderness, erythema and scaling. Scalp biopsies revealed considerable improvements in severe inflammation and perifollicular edema. Overall, clobetasol propionate 0.05% emollient foam was well-tolerated. Limitations: This was a nonrandomized, open-label study. Enrollment was limited to subjects with clinically mild CCCA. Conclusion: Subjects with CCCA that applied topical clobetasol propionate 0.05% emollient foam to their scalp daily demonstrated continuous clinical improvement throughout the 14-week study. ClinicalTrials.gov Identifier: NCT01111981 J Drugs Dermatol. 2020;19(7): doi:10.36849/JDD.2020.5201.

Global epidemiology and clinical spectrum of rosacea, highlighting skin of color: Review and clinical practice experience.

Rosacea has been reported less frequently among individuals with skin of color than in those with white skin, but rosacea is not a rare disease in this population. In fact, rosacea might be underreported and underdiagnosed in populations with skin of color because of the difficulty of discerning erythema and telangiectasia in dark skin. The susceptibility of persons with highly pigmented skin to dermatologic conditions like rosacea, whose triggers include sun exposure, is probably underestimated. Many people with skin of color who have rosacea might experience delayed diagnosis, leading to inappropriate or inadequate treatment; greater morbidity; and uncontrolled, progressive disease with disfiguring manifestations, including phymatous rosacea. In this article, we review the epidemiology of rosacea in skin of color and highlight variations in the clinical presentation of rosacea across the diverse spectrum of patient populations affected. We present strategies to aid in the timely diagnosis and effective treatment of rosacea in patients with skin of color, with an aim of promoting increased awareness of rosacea in these patients and reducing disparities in the management of their disease.

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.

Biotin Alone or a Science-Driven Nutraceutical Multi-Targeted Approach?

It is with great fervor that I revisit the article published in Journal of Drugs in Dermatology by Soleymani et al, titled "The Infatuation With Biotin Supplementation: Is There Truth Behind Its Rising Popularity? A Comparative Analysis of Clinical Efficacy versus Social Popularity."1 First, I'd like to thank the authors for raising awareness of the overuse of biotin for hair loss and reminding us of the struggle we are faced with daily when debunking quick-fix myths propagated by media infatuation.

Therapeutic Insights in Melasma and Hyperpigmentation Management

Melasma and postinflammatory hyperpigmentation (PIH) are the most common forms of dyschromia in patients with skin of color. Both are associated with a high psychological burden of disease. To exacerbate this burden, the need for treatment is chronic, and the results are often suboptimal in the eyes of the patient. Successful treatment is therefore contingent upon a correct diagnosis, patient education, and a carefully considered therapeutic approach. The latter is often multimodal in its design, incorporating sun protection, topical and systemic medications, and in some cases, procedural intervention. Although topical hydroquinone is a mainstay of treatment for melasma and PIH, there are alternatives that have emerged as of late that have shown varying degrees of promise, both in terms of safety and efficacy. In this article, we review the epidemiological, clinical, and histologic features of melasma and postinflammatory hyperpigmentation, and discuss important considerations for both established and emerging treatments for these vexingly common and difficult to treat conditions.

Myths and Knowledge Gaps in the Aesthetic Treatment of Patients With Skin of Color

Background: Misperceptions about facial aesthetic treatments in individuals with skin of color (SOC) may influence treatment selection. Objective: We aimed to identify knowledge gaps and myths concerning facial aesthetic treatment in individuals with SOC. Methods: A PubMed search identified articles concerning patients with SOC receiving facial aesthetic treatments. The experience of experts in aesthetic treatment of patients with SOC was also considered. Results: Knowledge gaps included not seeking injectable filler treatment of lips, risk of developing keloids with injectable filler treatment, risk of hyperpigmentation precluding surgical procedures and nonsurgical injectable filler treatment, melasma being a minor cosmetic concern with limited treatments, and racial/ethnic groups being homogeneous with respect to facial characteristics and aesthetic concerns. Dispelled myths included perceptions that: individuals with SOC do not need sunscreen; dermal fillers and neuromodulators are not necessary or useful for patients with darker skin; laser treatments cannot be used on darker skin; facial products are unnecessary; and only medical providers with SOC can understand how to treat patients with SOC. Conclusions: Knowledge gaps and myths concerning facial aesthetic treatment in individuals with SOC exist. These patients may undergo various facial aesthetic procedures safely and effectively, as long as nuances in treatment approaches are recognized. J Drugs Dermatol. 2019;18(7):616-622.

Final Data from the Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR)

Perceptions of attractiveness can be negatively affected by submental fullness. Patients seeking to improve their submental contour have a variety of treatment options including surgical procedures, energy-based devices, and injectable treatment. The Condition of Submental Fullness and Treatment Outcomes Registry (CONTOUR) was designed to provide insights into the treatment of submental fat (SMF) in clinical practice. CONTOUR was a prospective observational study that enrolled 1029 adults at 91 sites in the United States and Canada. Patients were followed until treatment completion, discontinuation, or 1 year elapsed from enrollment without treatment. Final data from CONTOUR are reported here. Of the 676 patients who underwent treatment, 570 were treated with ATX-101 (deoxycholic acid injection), 77 with energy-based devices, 23 with surgical liposuction, 5 with laser liposuction, and 9 with other treatments. The majority of treated patients were facial aesthetic treatment naive. A markedly greater percentage of patients with mild or moderate SMF at baseline received treatment with ATX-101 or energy-based devices, whereas the majority of patients undergoing liposuction had severe or extreme SMF. Physicians most frequently cited a preference for a noninvasive/minimally invasive procedure as the reason for choosing either ATX-101 or energy-based devices. The majority of patients were at least partially satisfied with results, regardless of the chosen treatment. Data from CONTOUR indicate that cost is the most important factor in a patient's decision to undergo treatment, that choice of treatment method is most influenced by SMF severity and preference for nonsurgical versus surgical intervention, and that the availability of noninvasive/minimally invasive options has made SMF treatment an attractive first procedure for patients who have not undergone previous facial aesthetic treatments. ClinicalTrials.gov identifier: NCT02438813. J Drugs Dermatol. 2019;18(1):40-48.

Efficacy, Safety, and Tolerability of Topical Dapsone Gel, 7.5% for Treatment of Acne Vulgaris by Fitzpatrick Skin Phototype.

BACKGROUND: Acne vulgaris (acne) is prevalent in individuals with skin of color, often with more frequent sequelae than in patients with lighter skin color. It is important to determine if there are also differences in response to medications. OBJECTIVE: This study evaluated the efficacy and tolerability of once-daily dapsone gel, 7.5% in patients with acne, stratified by Fitzpatrick skin phototype. METHODS: Data were pooled from 2 identically designed, phase 3, randomized, double-blind, vehicle-controlled studies in patients aged 12 years and older with moderate acne. Patients applied dapsone gel, 7.5% or vehicle once daily for 12 weeks. Efficacy was evaluated using the Global Acne Assessment Score (GAAS), lesion counts, and Acne Symptom and Impact Scale (ASIS); adverse events (AEs) and tolerability were also assessed. RESULTS: This analysis included 2216 patients with skin phototypes I-III and 2111 with types IV-VI. Dapsone gel, 7.5% significantly improved acne severity versus vehicle in both skin phototype subgroups, as determined by the percentage of patients with at least a 1-grade improvement in GAAS and mean change from baseline in GAAS (both, P less than .0001) at week 12 versus baseline. Dapsone gel, 7.5% significantly reduced inflammatory, comedonal, and total lesions in skin phototypes I-III (P less than .001) and IV-VI (P less than equal to .01) versus vehicle. Improvements in inflammatory lesions occurred first, with generally similar patterns of improvement seen over time in GAAS, comedonal lesions, and ASIS domains. The incidence of AEs was similar in both skin phototype subgroups and between study medications. Local scaling, erythema, stinging/burning, and dryness were rated "none" by most patients in both treatment groups and skin phototype subgroups. CONCLUSION: Once-daily dapsone gel, 7.5% was effective, safe, and well tolerated in patients with all skin phototypes who were treated for moderate acne. J Drugs Dermatol. 2018;17(2):160-167.

Central Centrifugal Cicatricial Alopecia: New Insights and a Call for Action.

Central centrifugal cicatricial alopecia (CCCA) is a common and progressive form of lymphocyte predominant scarring alopecia which impacts negatively on the quality of life of those affected. It is seen more commonly in women of African descent with prevalence ranging from 2.7% to 5.7%. Current postulates include genetic inheritance, with traction inducing hairstyling practices and hair chemicals as aggravating factors. Histology reveals a perifollicular lymphocytic inflammation of the lower infundibulum, premature desquamation of the inner root sheath, and fibrous connective tissue. Treatment remains challenging and is directed at suppressing and preventing the inflammation, thus aborting scarring, with surgical intervention reserved for those who have stable disease or absence of histological inflammation. Future research with more patient numbers, focusing on the genetics of CCCA may prove useful in order to fully understand the etiology, thus providing more effective treatments for CCCA.

New Insight Into the Pathophysiology of Hair Loss Trigger a Paradigm Shift in the Treatment Approach.

Hair loss affects millions of men and women of all ages and ethnicities, impacting appearance, social interactions, and psycho-emotional well-being. Although a number of options are available, they are limited, carry a potential risk of side effects, and none have proven to be comprehensive for treatment of hair loss. Across the spectrum of hair loss disorders, there has long been a segmentation into distinct mechanisms, driving the main trend in current therapeutics to focus on targeting single molecules or pathways. However, research points to similar dysregulation of intrinsic signaling pathways within follicle physiology that span the hair loss disorder spectrum - with a common inflammatory component identified in most hair loss pathogenesis, including that of androgenetic alopecia (AGA).

J Drugs Dermatol. 2017;16(11 Suppl):s135-140.

REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Injectable Drug for Submental Fat Reduction.

BACKGROUND: ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. OBJECTIVE: To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. METHODS: Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm) or placebo. Coprimary outcome measures were composite ≥1-grade and ≥2-grade improvements in clinician-assessed and subject-assessed SMF severity using validated scales at 12 weeks after last treatment. Magnetic resonance imaging (MRI) provided an objective measure of submental volume reduction. Patient-reported outcomes were assessed. RESULTS: Among 256 ATX-101-treated and 250 placebo-treated subjects, a ≥1-grade composite response was achieved in 70.0% and 18.6%, and a ≥2-grade composite response in 13.4% and 0%, respectively (p < .001 for both). The proportion of MRI responders was more than 8 times higher with ATX-101 than placebo (46.3% vs 5.3%; p < .001). ATX-101-treated subjects reported improvement in the psychological impact of SMF and satisfaction with treatment (p < .001 for all assessments vs placebo). Of note, 55% and 75% of ATX-101-treated subjects reported 1-grade improvement in clinician-assessed SMF after 2 and 4 treatments, respectively. Adverse events (primarily localized to the injection site) were mostly mild or moderate, and transient. Marginal mandibular nerve paresis reported in 4.3% of ATX-101-treated subjects (1.0% of all ATX-101 treatment sessions) was mostly mild, transient, and resolved without sequelae. CONCLUSION: ATX-101 is a safe and efficacious, first-in-class, injectable drug for SMF reduction.

The Efficacy and Safety of Topical Dapsone Gel, 5% for the Treatment of Acne Vulgaris in Adult Females With Skin of Color.

BACKGROUND: Topical dapsone gel, 5% is approved for treatment of acne vulgaris but has not been studied specifically in women with skin of color (SOC; Fitzpatrick skin types IV, V, or VI). OBJECTIVE: Evaluate safety and efficacy of dapsone gel, 5% applied topically twice daily for 12 weeks in women with SOC. METHODS: Females with SOC aged 18 years and older with facial acne participated in a multicenter, open-label, single-group, 12-week pilot study of twice-daily monotherapy with dapsone gel, 5%. The investigator-rated 5-point Global Acne Assessment Score (GAAS) was used to assess efficacy. The impact of acne on subjects was assessed using the validated Acne Symptom and Impact Scale (ASIS). RESULTS: The study enrolled and treated 68 women with SOC and facial acne. GAAS decreased significantly from baseline to week 12 (mean, -1.2 [95% CI, -1.4, -1.0]; P<.001), a 39.0% improvement. Overall, 42.9% of subjects were responders based on a GAAS of 0 or 1 at week 12. Subjects also experienced significant reductions in mean total lesions (52% decrease), inflammatory lesions (65%), and comedo counts (41%; all P<.001). Dapsone gel, 5% monotherapy was associated with significant improvement in subject-assessed acne signs (P<.001) and impact on quality of life (QOL; P<.001), based on ASIS. Dapsone gel, 5% used twice daily was well tolerated, with no treatment-related adverse events. The local dermal tolerability scores tended to remain stable or decrease from baseline to week 12. CONCLUSIONS: Monotherapy with dapsone gel, 5% administered twice daily was safe and effective for treatment of facial acne in women with SOC. Significant improvement in overall acne severity and both inflammatory lesions and comedones was observed. Further, study subjects reported considerable improvement in both acne signs and impact on QOL.