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Effectiveness of oral spironolactone for acne vulgaris in adult women


Professor Alison Layton

Honorary Professor


2019 to 2021


About the research

This study was a pragmatic, multicentre, phase 3, double-blind, randomised controlled trial conducted in England and Wales.

It aimed to evaluate the effectiveness of a tablet called l spironolactone, in treating acne vulgaris in adult women.

The participants, who had been dealing with facial acne for at least six months and were considered to need oral antibiotics, were randomly assigned to receive either 50 mg/day of spironolactone or a placebo for six weeks, after which time the dose of the medication assigned to the participant was increased to 100 mg/day until week 24.

They were allowed to continue using their usual topical (creams or gels) treatments.

Industry application

The research is relevant to the healthcare and pharmaceutical industries, particularly those involved in the development and application of acne treatments.

Study findings

The study found that spironolactone significantly improved acne symptoms compared to the placebo, with greater differences observed at week 24 than at week 12.

More participants in the spironolactone group reported acne improvement than in the placebo group, especially at week 24.

Treatment satisfaction was also higher in the spironolactone group although adverse reactions, particularly headaches, were slightly more common in the spironolactone group. However, no serious adverse reactions were reported.

This research is an important contribution to women’s health as it offers adult females with acne an alternative to oral antibiotics which are known to drive antimicrobial resistance which poses a global concern.


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 doi: (Published 16 May 2023)

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