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.

An open label study of clobetasol propionate 0.05% and betamethasone valerate 0.12% foams in the treatment of mild to moderate acne keloidalis.

Acne keloidalis (AK) is a disease affecting primarily African American men. Topical steroids are a widely accepted treatment of AK; however, no studies have been published investigating their effectiveness. The purpose of this open-label study was to assess the efficacy and tolerability of clobetasol propionate 0.05% and betamethasone valerate 0.12% foams in the treatment of AK in 20 African American patients. These patients were treated for 8 to 12 weeks using a pulsed-dose regimen. We found topical clobetasol propionate foam to be effective in improving AK, and our patients found the foam vehicle to be cosmetically acceptable.

Efficacy and Safety of Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel for the Treatment of Acne and Acne-induced Post-inflammatory Hyperpigmentation in Patients with Skin of Color.

OBJECTIVE: To assess the efficacy and safety of a topical gel containing clindamycin 1.2% and tretinoin 0.025% for the treatment of acne and acne-induced postinflammatory hyperpigmentation (PIH) in darker skinned patients. DESIGN: Randomized, double-blind, placebo-controlled study. SETTING: Two United States clinical sites. PARTICIPANTS: Thirty-three patients 12 years of age or older with skin types IV to VI, mild-to-moderate facial acne, and PIH were enrolled. MEASUREMENTS: Patients applied clindamycin phosphate/tretinoin gel or a nonmedicated vehicle each evening and a sun protection factor 30 sunscreen daily. Changes in skin erythema and hyperpigmentation were measured using a chromameter and photographic images. Efficacy was assessed using the Evaluators Global Acne Severity Scale, lesion counts, Post-inflammatory Hyperpigmentation Severity Scales and Patient's Global Assessment Scale. Safety and tolerability were assessed by adverse event reports and a Safety Assessment Scale. RESULTS: The mean (SD) baseline inflammatory lesion count was 11.9 (11.1) in clindamycin/tretinoin-treated patients, decreasing by 5.5 (6.56) after 12 weeks while the mean baseline inflammatory lesion count was 13.6 (11.15) in placebo-treated patients, decreasing by 4.1 (11.36) (p=0.05 for change from baseline, clindamycin/tretinoin vs. placebo). Clindamycin/tretinoin-treated patients generally demonstrated superior efficacy versus placebo treatment. The clindamycin/tretinoin topical gel was well tolerated, causing little or no irritation, although one patient withdrew due to periorbital edema of moderate severity possibly related to clindamycin/tretinoin gel. CONCLUSION: Although limited by small sample size, the results of this pilot study suggest clindamycin phosphate 1.2% and tretinoin 0.025% topical gel is a safe and effective option for treating mild-to-moderate acne in patients with skin of color.