Spironolactone as an Effective Treatment for Acne in Adult Women

The Spironolactone for Adult Female Acne, or SAFA, trial, which employed a pragmatic, multicenter, phase 3, double-blind, randomized controlled design to assess the impact of spironolactone on acne, revealed the effectiveness of oral spironolactone as a treatment for acne vulgaris in adult women.

The trial included women aged 18 years and older who had been dealing with facial acne for at least 6 months, and whose condition was judged to warrant oral antibiotics. Participants were randomly assigned to receive either 50 mg/day of spironolactone or a matched placebo for the initial 6 weeks. Subsequently, the dosage was increased to 100 mg/day of spironolactone or placebo for the remaining 18 weeks. Participants were permitted to continue using topical acne treatments.

The primary outcome measure for the study was the Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at week 12, which assessed the impact of treatment on the participants' quality of life. Secondary outcomes included Acne-QoL scores at week 24, self-assessed improvement by participants, the Investigator Global Assessment for treatment success, and the occurrence of adverse reactions.

The study involved 1267 women, with 342 included in the primary analysis. At baseline, the mean age was 29.2 years, and participants exhibited varying degrees of acne severity. Spironolactone significantly improved Acne-QoL scores at both week 12 and week 24 compared to the placebo, with greater differences noted at week 24. Additionally, more participants in the spironolactone group reported improvement in their acne compared to the placebo group, with a significant difference observed at week 24.

“Spironolactone improved outcomes compared with placebo, with greater differences at week 24 than week 12. Spironolactone is a useful alternative to oral antibiotics for women with acne,” concluded the study authors.

Reference
Santer M, Lawrence M, Renz S, et al. Effectiveness of spironolactone for women with acne vulgaris (SAFA) in England and Wales: pragmatic, multicentre, phase 3, double blind, randomised controlled trial. BMJ. 2023;381:e074349. doi:10.1136/bmj-2022-074349