Effectiveness of spironolactone for women with acne vulgaris (SAFA) in England and Wales: pragmatic, multicentre, phase 3, double blind, randomised controlled trial.

ABSTRACT:

Objective

To assess the effectiveness of oral spironolactone for acne vulgaris in adult women.

Design

Pragmatic, multicentre, phase 3, double blind, randomised controlled trial.

Setting

Primary and secondary healthcare, and advertising in the community and on social media in England and Wales.

Participants

Women (≥18 years) with facial acne for at least six months, judged to warrant oral antibiotics.

Interventions

Participants were randomly assigned (1:1) to either 50 mg/day spironolactone or matched placebo until week six, increasing to 100 mg/day spironolactone or placebo until week 24. Participants could continue using topical treatment.

Main outcome measures

Primary outcome was Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at

SUBMITTER: Santer M 

PROVIDER: S-EPMC10543374 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature