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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
Sponsor study identifier
interventional
40
1 country
1
Study Start
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 11, 2026
Actual (reported)March 16, 2026
Actual (reported)April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Measure the Change in Acne Severity via Global Acne Grading System (GAGS)
The GAGS is used to calculate acne severity separately for each half of the face. The face is divided into regions (forehead, cheeks, nose, chin) with assigned area factors. Each region is graded from 0 (no lesion) to 4 (nodule); the regional score is the product of the most severe lesion grade and the area factor
Baseline and 8 weeks (end of treatment)
Measure Comparative Change in Global Acne Grading System (GAGS) Score
8 weeks
Measure The Reduction in Total Lesion Count (TLC)
Baseline and 8 weeks
Measure Change in Quality of Life Using the Cardiff Acne Disability Index (CADI)
Baseline and 8 weeks.
Measure Patient Treatment Satisfaction Assessed by the Dermatology Treatment Satisfaction Questionnaire (DermSat-7)
8 weeks
Participants will apply topical 5% spironolactone nano-formulation gel to one side of the face once daily during the study period to evaluate its efficacy and safety in the treatment of acne vulgaris.
Participants will apply topical 0.1% adapalene gel to the opposite side of the face once daily during the study period for comparison of efficacy and safety.
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.
A third-generation retinoid applied once daily at night to the opposite half of the face.
Assiut University
Asyut, Egypt
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.
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.
First Submitted
March 11, 2026
First Posted
March 16, 2026
Study Start
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 17, 2026
Record last verified: 2026-03
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