As an alternative to oral antibiotics, spironolactone improved outcomes at week 24 in women with persistent acne, a placebo-controlled study shows. The Spironolactone for Adult Female Acne (SAFA) trial, the largest randomized trial to date, used a pragmatic design to “inform real world decision making for women with acne and to reflect the potential role of spironolactone in the clinical pathway,” the authors write.
Participants were 410 women with facial acne for at least 6 months whose conditions were judged to warrant oral antibiotics. Randomization to placebo or spironolactone produced these changes in Acne-Specific Quality of Life (Acne-QoL) symptom subscale scores at weeks 12 and 24: “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 (standard deviation 4.9) and at week 12 were 19.2 (6.1) for spironolactone and 12.9 (4.5) and 17.8 (5.6) for placebo (difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46), adjusted for baseline variables). Scores at week 24 were 21.2 (5.9) for spironolactone and 17.4 (5.8) for placebo (difference 3.45 (95% confidence interval 2.16 to 4.75), adjusted). More participants in the spironolactone group reported acne improvement than in the placebo group: no significant difference was reported at week 12 (72% v 68%, odds ratio 1.16 (95% confidence interval 0.70 to 1.91)) but significant difference was noted at week 24 (82% v 63%, 2.72 (1.50 to 4.93)). Treatment success (IGA classified) at week 12 was 31 (19%) of 168 given spironolactone and nine (6%) of 160 given placebo (5.18 (2.18 to 12.28)). Adverse reactions were slightly more common in the spironolactone group with more headaches reported (20% v 12%; P = 0.02). No serious adverse reactions were reported.”