Evaluation of Topical Dutasteride as a Potential New Therapy for Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)

Summary

Acne vulgaris (AV) is one of the most prevalent dermatological conditions worldwide, affecting approximately 85% of adolescents and young adults between the ages of 12 and 24 years .While acne is often self-limiting, it can have profound psychosocial implications as individuals with acne are more likely to experience emotional distress, lower self-esteem and anxiety disorders . Acne Vulgaris is a chronic inflammatory skin condition affecting the pilosebaceous units that leads to the development of different skin lesions such as comedones, papules, pustules, nodules and cystic lesions .

Timeline

Start

2026-04

Primary completion

2027-04

Completion

2028-04

Publications

• Background Voutilainen A, Pitkaaho T, Kvist T, Vehvilainen-Julkunen K. How to ask about patient satisfaction? The visual analogue scale is less vulnerable to confounding factors and ceiling effect than a symmetric Likert scale. J Adv Nurs. 2016 Apr;72(4):946-57. doi: 10.1111/jan.12875. Epub 2015 Dec 22.
• Background El-Husseiny R, Elframawy S, Abdallah M. Comparative study between fractional carbon dioxide laser vs intralesional steroid injection in treatment of alopecia areata. Dermatol Ther. 2020 Jul;33(4):e13742. doi: 10.1111/dth.13742. Epub 2020 Jul 9.
• Background Boonpethkaew S, Ratanapokasatit Y, Chirasuthat S, Wattanakrai P. Efficacy and safety of the 589/1319 nm solid-state dual-wavelength laser combined with topical benzoyl peroxide for inflammatory acne vulgaris: a split-face randomized controlled trial. Arch Dermatol Res. 2025 Mar 26;317(1):635. doi: 10.1007/s00403-025-04146-6.
• 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 Kim KY, Song SY, Jung YJ, Jue MS, Hong JY, Kim BJ, Ko JY. A Randomized, Split-Face, Comparative Study of a Combined Needle Radiofrequency/Intense Pulsed Light Device in Moderate-to-Severe Acne Patients. Ann Dermatol. 2024 Oct;36(5):266-274. doi: 10.5021/ad.23.083.
• Background Kim HJ, Kim YH. Exploring Acne Treatments: From Pathophysiological Mechanisms to Emerging Therapies. Int J Mol Sci. 2024 May 13;25(10):5302. doi: 10.3390/ijms25105302.
• Background Beylot C, Auffret N, Poli F, Claudel JP, Leccia MT, Del Giudice P, Dreno B. Propionibacterium acnes: an update on its role in the pathogenesis of acne. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):271-8. doi: 10.1111/jdv.12224. Epub 2013 Aug 1.
• Background Almudimeegh A, AlMutairi H, AlTassan F, AlQuraishi Y, Nagshabandi KN. Comparison between dutasteride and finasteride in hair regrowth and reversal of miniaturization in male and female androgenetic alopecia: a systematic review. Dermatol Reports. 2024 Apr 12;16(4):9909. doi: 10.4081/dr.2024.9909. eCollection 2024 Nov 21.
• Background Leyden J, Bergfeld W, Drake L, Dunlap F, Goldman MP, Gottlieb AB, Heffernan MP, Hickman JG, Hordinsky M, Jarrett M, Kang S, Lucky A, Peck G, Phillips T, Rapaport M, Roberts J, Savin R, Sawaya ME, Shalita A, Shavin J, Shaw JC, Stein L, Stewart D, Strauss J, Swinehart J, Swinyer L, Thiboutot D, Washenik K, Weinstein G, Whiting D, Pappas F, Sanchez M, Terranella L, Waldstreicher J. A systemic type I 5 alpha-reductase inhibitor is ineffective in the treatment of acne vulgaris. J Am Acad Dermatol. 2004 Mar;50(3):443-7. doi: 10.1016/j.jaad.2003.07.021.
• Background Panuganti VK, Kumar Madala P, Ramalingayya Grandhi V, Varma Alluri C, Mohammad J, Rao Kssvv S, Reddy Dundigalla M. A Randomized, Double-Blind, Placebo and Active Controlled Phase II Study to Evaluate the Safety and Efficacy of Novel Dutasteride Topical Solution (0.01%, 0.02%, and 0.05% w/v) in Male Subjects With Androgenetic Alopecia. Cureus. 2025 Aug 3;17(8):e89309. doi: 10.7759/cureus.89309. eCollection 2025 Aug.
• Background Del Rosso JQ, Kircik L. The cutaneous effects of androgens and androgen-mediated sebum production and their pathophysiologic and therapeutic importance in acne vulgaris. J Dermatolog Treat. 2024 Dec;35(1):2298878. doi: 10.1080/09546634.2023.2298878. Epub 2024 Jan 8.
• Background Gupta AK, Mann A, Vincent K, Abramovits W. CABTREOTM (Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide) Topical Gel. Skinmed. 2024 Oct 22;22(5):375-378. eCollection 2024.
• Background Stein Gold L, Baldwin H, Kircik LH, Weiss JS, Pariser DM, Callender V, Lain E, Gold M, Beer K, Draelos Z, Sadick N, Pillai R, Bhatt V, Tanghetti EA. Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug. Am J Clin Dermatol. 2022 Jan;23(1):93-104. doi: 10.1007/s40257-021-00650-3. Epub 2021 Oct 21.
• Background Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, Desai SR, Druby KM, Freeman EE, Keri JE, Stein Gold LF, Tan JKL, Tollefson MM, Weiss JS, Wu PA, Zaenglein AL, Han JM, Barbieri JS. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024 May;90(5):1006.e1-1006.e30. doi: 10.1016/j.jaad.2023.12.017. Epub 2024 Jan 30.
• Background Sutaria AH, Masood S, Saleh HM, Schlessinger J. Acne Vulgaris. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459173/

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Indications