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

Официальное название

Efficacy and Safety of Topical 5% Spironolactone Gel Nano-Formulation Versus 0.1% Adapalene Gel in the Management of Acne Vulgaris: A Split-Face Study

Обзор

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.

Подробное описание

Acne vulgaris is a chronic inflammatory disorder of the pilosebaceous unit that affects a large proportion of adolescents and young adults worldwide. The condition is characterized by the development of comedones, papules, pustules, and in severe cases nodules and cysts. The pathogenesis of acne involves multiple mechanisms including follicular hyperkeratinization, excessive sebum production stimulated by androgens, colonization with Cutibacterium acnes, and inflammatory responses within the pilosebaceous unit.

Topical retinoids are considered a cornerstone in the management of acne vulgaris due to their comedolytic and anti-inflammatory properties. Adapalene, a third-generation topical retinoid, is commonly used because of its efficacy and relatively favorable tolerability profile. Despite these advantages, some patients experience skin irritation, dryness, and erythema, which may limit adherence and treatment outcomes.

Spironolactone is an antiandrogen medication traditionally used orally for the treatment of hormonal acne, particularly in females. It acts by blocking androgen receptors and reducing sebaceous gland activity, thereby decreasing sebum production. However, systemic administration may be associated with potential adverse effects. Topical formulations of spironolactone have been proposed as an alternative approach to deliver antiandrogen effects locally while minimizing systemic exposure.

Recent advances in pharmaceutical technology, including nano-formulation delivery systems, may enhance the penetration and stability of topical medications and improve therapeutic outcomes. A topical 5% spironolactone gel nano-formulation may provide improved skin penetration and targeted delivery to the pilosebaceous unit.

The present study is designed as a split-face comparative clinical study to evaluate the efficacy and safety of topical 5% spironolactone gel nano-formulation compared with topical 0.1% adapalene gel in patients with acne vulgaris. In this design, each participant will apply spironolactone gel to one side of the face and adapalene gel to the other side according to the study protocol. This approach allows direct comparison of the two treatments within the same individual and minimizes inter-individual variability.

Eligible participants diagnosed with acne vulgaris will be recruited from dermatology clinics. Baseline clinical assessment will include evaluation of acne severity, lesion counts, and skin examination. Participants will receive instructions regarding the application of each topical treatment and follow-up visits will be scheduled throughout the study period to monitor treatment response and detect possible adverse events.

The primary outcome will be the change in acne lesion counts and clinical severity after the treatment period. Secondary outcomes will include evaluation of treatment tolerability, improvement in inflammatory and non-inflammatory lesions, and documentation of local adverse reactions such as erythema, dryness, burning sensation, or irritation.

The findings of this study may contribute to the growing body of evidence regarding topical antiandrogen therapy for acne and may support the use of spironolactone nano-formulation as an effective and safe topical treatment option for patients with acne vulgaris.

Вмешательства

• Препарат Spironolactone 5% Topical Gel
  This is a drug-loaded nanospanlastics dispersion (using Span 60 and Tween 40) fabricated via the ethanol injection technique. It is applied twice daily to one half of the face for 8 weeks.
• Препарат Adapalene 0.1% Topical Gel
  A third-generation retinoid applied once daily at night to the opposite half of the face.

Первичные конечные точки

• Measure the Change in Acne Severity via Global Acne Grading System (GAGS) [Срок оценки: Baseline and 8 weeks (end of treatment)]

Вторичные конечные точки (4)

• Measure Comparative Change in Global Acne Grading System (GAGS) Score [Срок оценки: 8 weeks]
• Measure The Reduction in Total Lesion Count (TLC) [Срок оценки: Baseline and 8 weeks]
• Measure Change in Quality of Life Using the Cardiff Acne Disability Index (CADI) [Срок оценки: Baseline and 8 weeks.]
• Measure Patient Treatment Satisfaction Assessed by the Dermatology Treatment Satisfaction Questionnaire (DermSat-7) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

Age: 18-45 years old.

• Patients with mild to moderate bilateral acne vulgaris on the face.
• Presence of non-inflammatory acne (open and closed comedones).
• Presence of inflammatory papules and pustules.

Критерии исключения

• Pregnancy and lactation.
• Patients taking oral contraceptive pills or any hormonal treatment.
• Patients who were using topical or systemic medications for acne in the last two months prior to starting therapy.
• Patients who had received laser resurfacing, chemical peeling, mesotherapy, or any similar facial interventions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Assiut University — Asyut

Публикации

• 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. PMID 17635508
• 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. PMID 40475110
• 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. PMID 38576244
• 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. PMID 37991774
• 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. PMID 38725769
• 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. PMID 39861676
• 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. PMID 39271178

Идентификаторы

NCT: NCT07473895 · AUN-DERM-ACNE-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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