Topical 5% Spironolactone Gel Versus 0.1% Adapalene Gel for Acne Vulgaris: A Randomized Split-Face Study

Summary

Acne vulgaris is one of the most common dermatological conditions affecting adolescents and young adults. It results from multiple pathogenic factors, including increased sebum production, follicular hyperkeratinization, colonization by Cutibacterium acnes, and inflammation. Topical retinoids such as adapalene are widely used as first-line therapy; however, they may cause irritation and are not always effective in all patients. Recently, topical antiandrogen therapies such as spironolactone have gained attention because of their ability to reduce sebum production and improve acne lesions. This study aims to evaluate the efficacy and safety of a topical 5% spironolactone gel nano-formulation compared with 0.1% adapalene gel in the treatment of acne vulgaris. A split-face study design will be used in which each participant will receive spironolactone gel on one side of the face and adapalene gel on the other side. This design allows each participant to serve as their own control and helps reduce variability in treatment response. Participants diagnosed with acne vulgaris will be enrolled and treated for a defined follow-up period. Clinical assessment will be performed at baseline and during scheduled follow-up visits to evaluate improvement in acne lesions and monitor possible adverse effects. The primary outcomes will include changes in acne lesion counts and clinical severity scores. Safety and tolerability of both treatments will also be assessed. The results of this study may provide evidence regarding the effectiveness of topical spironolactone nano-formulation as a potential alternative or adjunct therapy for acne vulgaris.

Timeline

Start

2026-04

Primary completion

2026-10

Completion

2026-12

Publications

• Background Charakida A, Charakida M, Chu AC. Double-blind, randomized, placebo-controlled study of a lotion containing triethyl citrate and ethyl linoleate in the treatment of acne vulgaris. Br J Dermatol. 2007 Sep;157(3):569-74. doi: 10.1111/j.1365-2133.2007.08083.x. Epub 2007 Jul 16.
• Background Elradi M, Hamed DE, Eltwansy MS, Hosny D. The Impact of Acne on Quality of Life: A Cross-Sectional Study from Egypt. Skin Appendage Disord. 2025 Jun;11(3):255-261. doi: 10.1159/000543051. Epub 2024 Dec 10.
• Background Bae IH, Kwak JH, Na CH, Kim MS, Shin BS, Choi H. A Comprehensive Review of the Acne Grading Scale in 2023. Ann Dermatol. 2024 Apr;36(2):65-73. doi: 10.5021/ad.23.094.
• Background Shields A, Armstrong AW, Kaur MN, Layton A, Thiboutot D, Tan J, Barbieri JS. Evaluation of DermSat-7 for Assessing Treatment Satisfaction in Patients with Acne. JAMA Dermatol. 2024 Jan 1;160(1):88-92. doi: 10.1001/jamadermatol.2023.4481.
• Background Althwanay A, AlEdani EM, Kaur H, Kasapoglu M, Yadavalli R, Nawaz S, Nath TS. Efficacy of Topical Treatments in the Management of Mild-to-Moderate Acne Vulgaris: A Systematic Review. Cureus. 2024 Apr 9;16(4):e57909. doi: 10.7759/cureus.57909. eCollection 2024 Apr.
• Background Dereiah S, Ghori MU, Conway BR. A Systematic Review of Spironolactone Nano-Formulations for Topical Treatment of Skin Hyperandrogenic Disorders and Chronic Wounds. Pharmaceutics. 2024 Dec 27;17(1):27. doi: 10.3390/pharmaceutics17010027.
• Background Zhu Z, Zhong X, Luo Z, Liu M, Zhang H, Zheng H, Li J. Global, regional and national burdens of acne vulgaris in adolescents and young adults aged 10-24 years from 1990 to 2021: a trend analysis. Br J Dermatol. 2025 Jan 24;192(2):228-237. doi: 10.1093/bjd/ljae352.

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