6/29/23, 11:41 PM SAFA Pathway Feedback Search Clinical Topics Home Studies SAFA SAFA Disease Acne vulgaris Trial question What is the effect of spironolactone in women with acne vulgaris? Study design Multi-center Double blinded RCT Population 410 female patients Inclusion criteria: adult women with facial acne for at least 6 months, judged to warrant oral antibiotics Key exclusion criteria: Investigator's Global Assessment acne score of 0-1; previous use of spironolactone; use of oral isotretinoin in the past 6 months; use of oral antibiotics for > 1 week for acne within the previous month Interventions N=201 spironolactone (50 mg/day until week 6, increasing to 100 mg/day until week 24) N=209 placebo (matching placebo) Primary outcome Improvement in Acne-Specific Quality of Life symptom subscale score at week 12 19.2 19.2 17.8 14.4 9.6 4.8 Significant increase 0.0 https://web.pathway.md/studies/recfv7P1VjnyLyeac 1/2 6/29/23, 11:41 PM SAFA Pathway 0 0 Spironolactone Placebo Significant increase in improvement in Acne-Specific Quality of Life symptom subscale score at week 12 (19.2 vs. 17.8; AD 1.27, 95% CI 0.07 to 2.46) Secondary outcomes Significant increase in improvement in Acne-Specific Quality of Life symptom subscale score at week 24 (21.2 vs. 17.4; AD 3.45, 95% CI 2.16 to 4.75) Borderline significant increase in self-assessed overall improvement score of 3-6 at week 24 (82% vs. 63%; OR 2.72, 95% CI 1.5 to 4.93) Borderline significant increase in Investigator's Global Assessment for treatment success at week 12 (19% vs. 6%; OR 5.18, 95% CI 2.18 to 12.28) Safety outcomes No significant differences in dizziness, drowsiness, fatigue. Significant differences in at least one adverse reaction (64% vs. 51%), headache (20% vs. 12%). Conclusion In adult women with facial acne for at least 6 months, judged to warrant oral antibiotics, spironolactone was superior to placebo with respect to improvement in Acne-Specific Quality of Life symptom subscale score at week 12. Reference Miriam Santer, Megan Lawrence, Susanne Renz et al. Effectiveness of spironolactone for women with acne vulgaris (SAFA) in England and Wales: pragmatic, multicentre, phase 3, double blind, randomised controlled trial. BMJ. 2023 May 16;381:e074349. Open reference URL https://web.pathway.md/studies/recfv7P1VjnyLyeac 2/2