RCT | Spironolactone enhances acne outcomes and offers a viable alternative to oral antibiotics

Summary: The SAFA (Spironolactone for Adult Female Acne) trial was a multicenter, phase 3, double-blind, randomized controlled trial in England and Wales and evaluated the efficacy of spironolactone for treating adult women with acne vulgaris. A total of 410 women, aged ≥18 years and suffering from facial acne for a minimum of six months, were randomly assigned to receive either 50 mg/day of spironolactone or a placebo, increasing to 100 mg/day until week 24.

The primary outcome was measured by the Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at week 12 and 24. The trial demonstrated that spironolactone improved Acne-QoL scores more effectively than the placebo, particularly at week 24. Additionally, more participants in the spironolactone group reported acne improvement, and treatment success was significantly higher in this group at week 12. Mild side effects, notably headaches, were more common in the spironolactone group.

The findings from the SAFA trial highlight spironolactone’s effectiveness, safety, and tolerability in treating adult women with acne vulgaris, suggesting it is a viable alternative to long-term antibiotic treatments. Future research is proposed on higher initial dosages of spironolactone, and its effects on different subgroups like patients with different ages, body mass index, and ethnicity.

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

Editorial: What do we know about prescribing spironolactone for acne? – The BMJ

News Release: Non-antibiotic treatment for women with persistent acne shown to be effective – University of Southhampton