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. 2025 Aug;24(8):e70411.
doi: 10.1111/jocd.70411.

Efficacy and Safety of Oral Spironolactone for Women With Acne Vulgaris: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials With Trial Sequential Analysis

Laura Ghanem  1 , Najwaa Kirmani  2 , Nathalia De León Fernández  3 , María Paula Palacios-Ortiz  4 , Juan David Rodríguez-Parra  5 , Corina A Rusu  6
Affiliations

Efficacy and Safety of Oral Spironolactone for Women With Acne Vulgaris: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials With Trial Sequential Analysis

Laura Ghanem et al. J Cosmet Dermatol. 2025 Aug.

Abstract

Background: Adult acne vulgaris is a chronic inflammatory skin condition that primarily affects females. Initial management includes topical and oral medications, but important limitations include ineffectiveness, nonadherence, and adverse effects. Spironolactone has shown good results in off-label acne management.

Aims: We aim to conduct a systematic review and meta-analysis exploring the safety and efficacy of oral spironolactone for females with acne.

Methods: We searched PubMed, Embase, and Cochrane for randomized controlled trials (RCTs) comparing oral spironolactone in women with acne to placebo. The primary endpoint was the objective assessment of acne improvement. Secondary endpoints included subjective assessment and adverse events. Statistical analysis was performed using Review Manager 5.4. Heterogeneity was assessed with I2 statistics.

Results: We included 563 patients from 5 RCTs, of which 251 (42.9%) received spironolactone. Objective assessment of acne improvement (OR 6.59; 95% 3.50-12.43; p < 0.00001; I2 = 0%) was sixfold higher in the spironolactone group compared with placebo. Subjective assessment showed no difference between the two groups (OR 5.22; 95% 0.62-44.24; p < 0.13; I2 = 85%). Menstrual irregularities (OR 1.09; 95% 0.37-3.25; p = 0.88; I2 = 33%) and breast enlargement (OR 1.37; 95% 0.79-2.38; p = 0.26; I2 = 0%) were nonsignificant in patients taking spironolactone. Trial sequential analysis (TSA) confirmed that the required sample size was reached, favoring spironolactone over placebo.

Conclusion: Our study suggests that oral spironolactone improves acne in female patients compared to placebo without increasing risks; thus, it should be elevated from "off-label" use to an officially recommended standard of care.

Prospero registration: CRD42024626984.

Keywords: acne vulgaris; spironolactone; women.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
PRISMA flow diagram of study screening and selection.
FIGURE 2
FIGURE 2
The severity of acne vulgaris was significantly reduced in women taking spironolactone as compared to placebo, following the objective and subjective assessment. CI, confidence interval; IV, inverse variance; OR, odds ratio; SE, standard error.
FIGURE 3
FIGURE 3
The severity of menstrual irregularities is not significantly seen in women taking spironolactone for acne vulgaris up to 12 weeks. CI, confidence interval.
FIGURE 4
FIGURE 4
The severity of breast enlargement is higher in women taking spironolactone for acne vulgaris compared with placebo. CI, confidence interval.
See this image and copyright information in PMC

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