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.

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.

Do Women with Skin of Color Think They Are Well Represented in Skin Aging Prevention Information?

Objective: There are clinical differences in healthy skin requirements and skin-aging features by race and ethnicity. However, individuals of color are underrepresented in dermatology-related medical information. We sought to gather information from women of color regarding their attitudes about the importance of the prevention of skin aging, available information, and perception of representation in skin-aging prevention information. Methods: This study involved an observational, cross-sectional, online survey of women aged 18 to 70 years residing in the United States. Participants were placed into one of seven cohorts based on self-reported race/ethnicity. Relative frequencies of responses were compared across cohorts; adjusted logistic regression was used to assess perception of representation in skin-aging prevention information. Results: The mean age of the 1,646 participants was 44.4 years. The mean (standard deviation) rating (from 0, "not at all important" to 10, "extremely important") of the importance of the prevention of skin aging ranged from 7.3 to 8.2 across the seven cohorts. All cohorts reported the most trusted source of information for skin-aging prevention products and treatments was a skin-care professional, but not all cohorts believed they are well represented in available sources of information. Older age, lower median household income, and a race/ethnicity of Black, Asian, "Other," and "More Than One Race" were less likely to report being well represented. Limitations: People without internet access could not participate, potentially excluding some older and lower-income groups. Conclusion: Women of color are less likely to feel represented in available information on the prevention of skin aging.

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.

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.

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.

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.

Diagnosing Disorders of Facial Erythema.

Identification of specific patterns, shades, and intensity of erythema in the skin has always been critical and fundamental to diagnostic accuracy in dermatology. Erythema is often less noticeable in darker skin types. The interplay of inflammation and variance of skin tone contributes to appreciable differences in the clinical appearance of cutaneous disease in darker complexions. In this article, we discuss common disorders that present with facial erythema in skin of color and offer distinguishing features of each disorder to assist the clinician with diagnosing these conditions in the presence of deeply pigmented skin.

Aesthetic considerations for treating the North American multi-ethnic patient: Thriving in diversity international roundtable series.

BACKGROUND: The United States is becoming increasingly diverse, and between 2016 and 2019, an increase of 945 832 aesthetic procedures was recorded for Hispanic, African American, and Asian American patients combined. In aesthetics, where outcomes are technique dependent and tied to the clinician's ability to tailor treatment to the needs of individual patients, a knowledge of ethnic differences in anatomy and how aesthetic issues can be safely and effectively addressed in different groups is paramount. AIMS: To discuss similarities and difference in anatomy and treatment preferences of patients from a variety of ethnic and racial backgrounds and how these differences may influence the products or techniques utilized to achieve natural-looking results and minimize side effects. PATIENTS/METHODS: In support of clinicians who wish to serve a diverse patient population, a 6-part international roundtable series focused on diversity in aesthetics was conducted from August 24, 2021, to May 16, 2022. RESULTS: The results of the first roundtable in the series, the North American Multiethnic Patient, are described here. CONCLUSIONS: A diverse range of patients can benefit from the tailored use of fillers, fat transfer, neuromodulators, lasers, and energy-based devices, as long as differences in structural support, skin, and aging patterns, are appreciated.

Effects of Topical Retinoids on Acne and Post-inflammatory Hyperpigmentation in Patients with Skin of Color: A Clinical Review and Implications for Practice.

Acne is a common cause for post-inflammatory hyperpigmentation (PIH), particularly in patients with skin of color (SOC), and PIH is often more distressing to patients than the acne itself. Topical retinoids are approved for the treatment of acne and for pigmentation disorders such as melasma or mottled hyperpigmentation associated with photodamage; moreover, they have been shown to reduce hyperpigmentation in patients with SOC. Therefore, treatment with topical retinoids should be started as early as possible unless contraindicated. Use of novel formulations or application of commonly recommended moisturizers may help reduce irritation. Combining retinoids with other topical agents and procedures such as superficial chemical peels can help to improve hyperpigmentation. Primary acne lesions are likely to improve weeks before PIH resolves and helping patients manage their expectations may reduce frustration. Providing clinicians and researchers with more education about the presentation and management of dermatologic conditions in patients with SOC is also recommended.

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.

Central Centrifugal Cicatricial Alopecia: Challenges and Treatments.

Central centrifugal cicatricial alopecia (CCCA) is the most common form of primary scarring alopecia diagnosed in women of African descent. Although the etiology was originally attributed exclusively to hairstyling practices common among women of African descent, more recent research on CCCA supports the concept that there are several contributing factors, including variants in gene expression, hair grooming practices that increase fragility on the hair follicle, and associations with other systemic conditions. Treatment of CCCA involves a combination of patient counseling and education on alternative hairstyles, medical therapies, and procedural methods when necessary.

Skin cancer in women of color: Epidemiology, pathogenesis and clinical manifestations.

Malignant melanoma and nonmelanoma skin cancers (NMSC), which include basal cell carcinoma and squamous cell carcinoma, account for 40% of all neoplasms in white patients, making these cancers the most common malignancy in the United States. Given the large number of NMSC cases in white patients, there is a correspondingly large body of literature addressing various aspects of epidemiology, pathogenesis, and treatment. The incidence of both malignant melanoma and NMSC is well established and remains significantly lower in patients with skin of color (SoC) when compared with white patients. Although there is a lower incidence of skin cancer in SoC, there is often a poorer prognosis among this group. There is even more limited data focusing on women of color, making an accurate determination of incidence and mortality difficult. This gender disparity causes decreased skin cancer awareness and index of suspicion among patients and providers, hindering appropriate evaluation and care. Therefore, there is a need for an increased understanding of skin cancer in women of color. In the traditional sense, SoC refers to people of African, Asian, Native American, Middle Eastern, and Hispanic backgrounds. Patients in these ethnic groups have richly pigmented skin that is usually categorized as Fitzpatrick types III through VI and thus have notable differences in skin disease and presentation compared with fair-skinned individuals. We present this review of skin cancer in women of color to give a reasonably comprehensive representation of the literature to advance our understanding and knowledge in this unique population.

The art of prevention: It's too tight-Loosen up and let your hair down.

Traction alopecia is prevalent in patients of color. Its significance in clinical practice may be underemphasized due to the transient nature of the condition; however, it has the potential to become permanent and cause significant psychosocial distress. Understanding of afro-textured hair and cultural practices, as well as early recognition and treatment, provides an opportunity to prevent permanent traction alopecia and long-term sequelae.

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.

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.