RF04 Oral spironolactone for adult female acne (SAFA): a multicentre, double-blind, randomized trial

Abstract Acne is common and results in significant burden patients with acne frequently receive prolonged oral antibiotics leading to antimicrobial resistance. Oral spironolactone prescribed for acne, although there a paucity of evidence on its effectiveness. The aim this pragmatic parallel, double-blind, superiority trial was assess the effectiveness systemic adult women. Participants were identified through primary secondary health care community social media advertising. Women aged ≥ 18 years facial at least 6 months, judged warrant antibiotics, invited participate. Consented recruits randomized 1 : either 50 mg daily or matched placebo until week 6, increasing 100 24. Topical treatment could be continued. outcome Acne-Specific Quality Life (Acne-QoL) symptom subscale score 12. Secondary outcomes included Acne-QoL 24, participant self-assessed improvement, Investigator’s Global Assessment (IGA) adverse effects. Of 1267 women assessed, 410 (201 intervention, 209 control) 342 analysis. Baseline mean (SD) age 29.2 (7.2) years, 7.9% (n = 28/356) non-White background, 46% had mild 40% moderate 13% severe (IGA classified). Eighty-three per cent used topical treatments. Over 95% both groups tolerated increased dosage. Mean scores baseline 12 13.2 (4.9) 19.2 (6.1) 12.9 (4.5) 17.8 (5.6) placebo, respectively {difference favouring 1.27 [95% confidence interval (CI) 0.07–2.46]}. Scores 24 21.2 (5.9) 17.4 (5.8) [difference 3.45 (95% CI 2.16–4.75)]. also favoured 12, greater differences More participants reported improvement than those placebo. At difference not statistically [72.2% vs. 67.9%; odds ratio (OR) 1.16, 0.70–1.91], but it (81.9% 63.3%; OR 2.72, 1.50–4.93). Treatment success classified) 31/201 9/209 (OR 5.18, 2.18–12.28). Adverse reactions serious similar between groups, more headaches by (20.4% 12.0%; P 0.02). Spironolactone improved This study supports as potential alternative