Acne that continues into adulthood, along the jaw and chin, is common in women, and it often comes with a hormonal pattern. Spironolactone is a medicine that blocks androgen activity, and it is used for this acne in many places. Until recently its evidence came from small studies. This article looks at the largest placebo-controlled trial, the SAFA study, and at what it can and cannot answer.
Who the trial studied
The SAFA trial randomized 410 women aged 18 or older with persistent facial acne in England and Wales, in a double-blind, placebo-controlled design. Women took 50 mg of spironolactone a day, increased to 100 mg a day until week 24, or a matched placebo. Topical treatments were allowed. The analysis adjusted for site, baseline severity, hormonal contraception and polycystic ovary syndrome.
The main measure: quality of life
The primary outcome was the Acne-QoL symptom subscale at week 12. The adjusted mean difference favored spironolactone by 1.27 points (95% CI 0.07 to 2.46). That is a real but small difference on the scale, and the result sits close to the lower edge of its confidence interval.
Clear skin, and the week 24 picture
At week 12, 19% of women on spironolactone had treatment success on the Investigator Global Assessment, against 6% on placebo. By week 24, 82% of women on spironolactone said their skin had improved, against 63% on placebo (odds ratio 2.72, 95% CI 1.50 to 4.93). The investigators did not measure IGA at week 24, so the later improvement is a self-report.
Side effects
Adverse reactions were slightly more common on spironolactone. Headache was reported by 20% against 12% on placebo (p=0.02). The trial reported no serious adverse reactions.
Where spironolactone sits in the guideline
The American Academy of Dermatology’s 2024 guideline makes a conditional recommendation for spironolactone in acne, which means it applies to most patients but individual factors can change the best choice. It makes strong recommendations for topical retinoids, benzoyl peroxide and oral doxycycline. The guideline also advises limiting systemic antibiotics and pairing them with topical therapy.
A 2026 narrative review notes that head-to-head studies show spironolactone with comparable or superior efficacy to doxycycline. We did not find a placebo-controlled trial of doxycycline in women that would let us compare the two directly, so we do not quote doxycycline figures here.
What this does not say
- The trial population was women with persistent facial acne in one country, and its results do not extend to men or to other kinds of acne without study.
- The trial reports to week 24. Results beyond that point are not in it, and the trial could not address pregnancy. A physician reviews this before any prescription.
- The trial used spironolactone at the doses listed, with topical treatments allowed. Compounded versions were not studied in it. These are averages, not a prediction for one woman.
- Quality of life moved by a small amount at week 12. A week 12 gain on a scale is not the same as a change a woman will feel every day.
How we use this
Spironolactone is a prescription decision for a physician, made after a consult that looks at your history and the medicines you already take. We follow your skin over months, because the trial measured results at 12 and 24 weeks, and we adjust if it is not working.
If hormones are part of your picture, bring that up in the consult. We will explain what the trial showed and what it did not.
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- 1.Santer M, Lawrence M, Renz S, 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;381:e074349. BMJ
- 2.Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol 2024. Journal of the American Academy of Dermatology
- 3.Łyko M, Złotowska A, Jankowska-Konsur A. Oral and topical spironolactone in adult female acne: a narrative review comparing systemic and local approaches. Clin Cosmet Investig Dermatol 2026. Clinical, Cosmetic and Investigational Dermatology
- 4.Layton et al. Systematic review of the impacts of acne on health-related quality of life (101 studies). Am J Clin Dermatol 2025;27. American Journal of Clinical Dermatology