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

作者：Miriam Santer, Megan Lawrence, Susanne Renz, Zina Eminton, Beth Stuart, Tracey Sach, Sarah Pyne, Matthew J Ridd, Nick Francis, Irene Soulsby, Karen Thomas, Natalia Permyakova, Paul Little, Ingrid Müller, Jacqui Nuttall, Gareth Griffiths, Kim S Thomas, Alison Layton · 发表于：BMJ · 年份：2023 · DOI：10.1136/bmj-2022-074349 · 被引用次数：60 · 研究领域：Acne and Rosacea Treatments and Effects、Hidradenitis Suppurativa and Treatments、Dermatology and Skin Diseases

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 week 12 (range 0-30, where higher scores reflect improved QoL). Secondary outcomes were Acne-QoL at week 24, participant self-assessed improvement; investigator’s global assessment (IGA) for treatment success; and adverse reactions. Results From 5 June 2019 to 31 August 2021, 1267 women were assessed for eligibility, 410 were randomly assigned to the intervention (n=201) or control group (n=209) and 342 were included in the primary analysis (n=176 in the intervention group and n=166 in the control group). Baseline mean age was 29.2 years (standard deviation 7.2), 28 (7%) of 389 were from ethnicities other than white, with 46% mild, 40% moderate, and 13% severe acne. Mean Acne-QoL symptom scores at baseline were 13.2 (standa...