RCT Results: Does Spironolactone Improve Acne for Women?
BACKGROUND AND PURPOSE:
- Spironolactone is often prescribed off-label for the treatment of acne, and may be useful in reducing antibiotic use in this setting
- Santer et al. (BMJ, 2023) assessed the effectiveness of oral spironolactone for acne vulgaris in adult women
METHODS:
- Pragmatic, multicenter, phase 3, double blind, randomized controlled trial
- Spironolactone for women with acne vulgaris (SAFA) trial
- England and Wales
- Participants
- Women ≥18 years
- Facial acne for ≥6 months
- Appropriate to use oral antibiotics for acne treatment
- Interventions
- Spironolactone
- 50 mg/day until week 6, increasing to 100 mg/day until week 24
- Placebo
- Spironolactone
- Study design
- Acne-Specific Quality of Life (Acne-QoL) scores range from 0 to 30
- Higher scores indicate improved QoL
- Acne-Specific Quality of Life (Acne-QoL) scores range from 0 to 30
- Primary outcomes
- Acne-QoL symptom subscale score at week 12
- Secondary outcomes
- Acne-QoL at week 24
- Participant self-assessed improvement
- Investigator’s global assessment (IGA) for treatment success
- Adverse reactions
RESULTS:
- Spironolactone: 176 women | Placebo: 166 women
- Mean age 29.2 years | Ethnicities other than White: 7%
- Mild acne: 46% | Moderate acne: 40% | Severe acne: 13%
- Mean Acne-QoL symptom scores
- More participants in the spironolactone group reported acne improvement
- There was no significant difference at week 12
- Spironolactone: 72% | Placebo: 68%
- OR 1.16 (95% CI, 0.70 to 1.91)
- There was a significant difference at week 24
- Spironolactone: 82% | Placebo: 63%
- OR 2.72 (95% CI, 1.50 to 4.93)
- There was no significant difference at week 12
- Treatment success (IGA classified) at week 12 was greater in the spironolactone group
- Spironolactone: 19% | Placebo: 6%
- OR 5.18 (95% CI, 2.18 to 12.28)
- Adverse reactions were slightly more common in the spironolactone group
- More headaches were reported (20% vs 12% | P=0.02)
- There were no serious adverse reactions
CONCLUSION:
- Compared to placebo, spironolactone improved acne symptoms at week 24
- There was no difference from the placebo group at week 12
- That authors state
The findings from this trial show the effectiveness, safety, and tolerability of spironolactone in women with acne
Adopting a combined approach using oral spironolactone and topical agents has the potential to reduce the long term prescribing of oral antibiotics and therefore to reduce the likelihood of emerging bacterial resistance
Treatment courses of spironolactone over three months are likely of greater benefit than shorter treatment duration
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