Spironolactone for Acne: Four Checks on the SAFA Trial

If spironolactone comes up at an acne appointment, bring the names of your creams and tablets, how long you have used them and what still bothers you. Put the treatment start date in your notes so follow-up has a clear reference point.

Our adult-acne guide covers the broader assessment and treatment discussion.

Check who was studied and what they continued

SAFA randomized 413 adult women; 410 remained in the analysis population after three exclusions. They had persistent facial acne judged to warrant oral antibiotics. Usual topical treatments could continue. The trial compared spironolactone with placebo, using active doses of 50 mg daily, increasing to 100 mg at six weeks if tolerated. NIHR funded it.¹

The British Association of Dermatologists² describes acne treatment with spironolactone as off-licence in the UK. It says the medicine can control acne but is not a cure. Ask which topical treatments belong in your own plan and whether any should change.²

Check the 12-week primary measure

The primary outcome was an acne quality-of-life symptom score, ranging from 0–30, with higher scores better. At 12 weeks, the adjusted difference favored spironolactone by 1.27 points (95% confidence interval 0.07–2.46). This measures a questionnaire score, not the proportion with clear skin.¹

For your review, describe the change you hope to notice: fewer painful spots, fewer new marks or less time spent covering breakouts. Ask how you and the clinician will measure it alongside the skin examination.

Check what counted as improvement at 24 weeks

At 24 weeks, self-reported improvement occurred in 131/160 (82%) with spironolactone versus 81/128 (63%) with placebo. This included slight improvement. These were respondents with available data, not all randomized women. Later follow-up to 52 weeks was unblinded and allowed other treatments, limiting comparisons.¹

Record the start date and take the same appointment notes to each review. Add any changes to the prescribed dose or topical treatments, so the clinician can see what you used between visits.

Check monitoring and pregnancy plans before starting

The dermatology leaflet lists breast tenderness, menstrual changes and dizziness among possible effects. It says raised potassium is more likely after age 45, with heart or kidney problems, or with medicines affecting potassium. Blood checks should reflect those risks; ask what you need before treatment and during follow-up.²

The current UK product information lists significant kidney impairment, Addison’s disease and high potassium among contraindications. Potassium supplements, potassium-containing salt substitutes, some blood-pressure medicines and co-trimoxazole (trimethoprim/sulfamethoxazole) can increase potassium risk. Bring the full medication and supplement list to the prescribing review.³

The American Academy of Dermatology⁴ says to stop spironolactone if pregnant and avoid it during pregnancy. Discuss pregnancy prevention and plans to conceive with your prescriber before starting acne treatment.⁴

Leave with a written plan

Ask: “Which treatments do I keep using? When will you assess the acne response? What monitoring do I need, and who should I contact about side effects or a possible pregnancy?”

What to Say at the Appointment in Skin, Head to Toe helps organize the question, your product and medicine history, pregnancy plans and the effect a skin problem has on daily life.