Improvement in Skin Moisturization and Lack of Barrier Damage Following Treatment With Clascoterone Cream 1%

April 2025 | Volume 24 | Issue 4 | 397 | Copyright © April 2025


Published online March 29, 2025

doi:10.36849/JDD.8774

Zoe D. Draelos MDa, Kizito Kyeremateng PharmDb, Nicholas Squittieri MDb

aDermatology Consulting Services, PLLC, High Point, NC
bSun Pharmaceutical Industries, Inc., Princeton, NJ

Abstract
Background: Topical medications commonly prescribed for the treatment of acne vulgaris may be limited by application-site dryness, which can result in skin barrier damage. This study aimed to evaluate the effects of clascoterone cream 1% on skin barrier properties in acne-prone individuals.
Methods: Participants ≥18 years of age with acne-prone skin were enrolled in a single-center, split-face study and randomized to twice-daily treatment with clascoterone cream 1% (approximately 0.5 g) to the right or left side of the face for 2 weeks. The primary and secondary endpoints were the changes in corneometry reading and transepidermal water loss (TEWL), respectively, between treated and untreated sides at week 2. Tolerability was evaluated from the severity of dryness, erythema, scaling, irritation, tightness, stinging, itching, and burning for each side using a 5-point scale from 0 (none) to 4 (severe).
Results: This study enrolled 50 participants (female, n = 38) with a mean ± standard deviation (SD) age of 31.1 ± 8.9 years. The mean ± SD corneometry reading was significantly higher for the treated vs untreated side at week 2 (131.3 ± 42.9 vs 113.9 ± 36.6; P<0.001). There was no difference in TEWL between treated and untreated sides at any time point assessed. All tolerability parameters evaluated were rated as absent or minimal through week 2 for both sides.
Conclusion: Twice-daily treatment with clascoterone cream 1% for 2 weeks was associated with increased moisturization and maintenance of skin barrier function as assessed by corneometry and TEWL and was otherwise well tolerated.

J Drugs Dermatol. 2025;24(4):397-402. doi:10.36849/JDD.8774

INTRODUCTION

Acne vulgaris is one of the most prevalent dermatologic conditions in the US and worldwide.1,2 Although acne typically presents during adolescence, it is a chronic condition that can persist into adulthood.1 The physical and psychological impacts of acne are often consequential for patients and can include pain, erythema, scarring, anxiety, and depression,3,4 highlighting the importance of early and effective treatment for patients with acne. Despite the range of acne treatments available, limitations in tolerability may contribute to the high rate of nonadherence to acne medications,5-7 which can impact efficacy and treatment success.8

As outlined in the American Academy of Dermatology guidelines, topical treatments are recommended as first-line agents in the treatment of acne vulgaris; however, therapies such as retinoids (eg, adapalene) and benzoyl peroxide may be limited by adverse effects, including dryness and irritation that can result in skin barrier damage and decreased patient adherence.4,9-14 Topical agents with improved, less irritating vehicle formulations15 or concomitant use of moisturizers11,16 can improve tolerability and mitigate skin barrier damage during acne treatment, but adverse effects may still be a concern - particularly with combinations of 2 or more topical agents.17 Several new and effective topical treatment options for acne introduced within the past decade may provide better tolerability and therefore improve patient adherence.18,19

Clascoterone cream 1%, a topical androgen receptor inhibitor, is a first-in-class therapy approved in the US in 2020 (with subsequent approvals in Canada and Australia) for the treatment of acne vulgaris in patients greater than or equal to 12 years of age.20-23 The effect of clascoterone is attributed to competition with dihydrotestosterone for binding to androgen receptors within the skin, thereby preventing the transcription of androgen-responsive genes and decreasing sebum production.24 The efficacy and safety of clascoterone cream 1% were established in two 12-week, randomized, double-blind, phase 3 clinical