Clinical and cost-effectiveness of spironolactone in treating persistent facial acne in women: SAFA double-blinded RCT

作者：Miriam Santer, Megan Lawrence, Sarah Pyne, Susanne Renz, Beth Stuart, Tracey Sach, Matthew J Ridd, Kim S Thomas, Jacqueline Nuttall, Natalia Permyakova, Zina Eminton, Nick Francis, Paul Little, Ingrid Müller, Irene Soulsby, Karen Thomas, Gareth Griffiths, Alison Layton · 发表于：Health Technology Assessment · 年份：2024 · DOI：10.3310/myjt6804 · 被引用次数：8 · 研究领域：Acne and Rosacea Treatments and Effects、Dermatologic Treatments and Research、Advancements in Transdermal Drug Delivery

Background: Acne is common, can cause significant impact on quality of life and is a frequent reason for long-term antibiotic use. Spironolactone has been prescribed for acne in women for many years, but robust evidence is lacking. Objective: To evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women. Design: Pragmatic, parallel, double-blind, randomised superiority trial. Setting: Primary and secondary healthcare and community settings (community and social media advertising). Participants: Women aged 18 years and older with facial acne persisting for at least 6 months, judged to potentially warrant oral antibiotic treatment. Interventions: Participants were randomised 1 : 1, using an independent web-based procedure, to either 50 mg/day spironolactone or matched placebo until week 6, increasing to 100 mg/day spironolactone or matched placebo until week 24. Participants continued usual topical treatment. Main outcome measures: Primary outcome was the adjusted mean difference in Acne-Specific Quality of Life symptom subscale score at 12 weeks. Secondary outcomes included Acne-Specific Quality of Life total and subscales; participant self-assessed improvement; Investigator's Global Assessment; Participant's Global Assessment; satisfaction; adverse effects and cost-effectiveness. Results: Of 1267 women assessed for eligibility, 410 were randomised (201 intervention, 209 control), 342 in the primary analysis (176 intervention, 166 cont...