Spironolactone is usually given to people for high blood pressure. It is also thought to lower hormones that trigger grease production by the skin. Doctors have prescribed spironolactone ‘off-licence’ for women with acne for over 30 years, without robust evidence that it works.
If shown to be effective, spironolactone could replace antibiotics as a treatment for acne in women. Rising rates of antibiotic resistance mean alternative treatments are needed.
Women taking part in the study, known as SAFA (Spironolactone for Adult Female Acne), will be randomly assigned to a group that will take either the spironolactone tablet or a matching placebo (‘dummy’ tablet) for six months.
The Bristol Royal Infirmary (BRI) is one of five hospitals helping to recruit patients. General practices near the hospitals will also be asked to contact any patients they think might want to take part.
Dr Matthew Ridd, a GP and Reader in Primary Care Research in the Centre for Academic Primary Care at the University of Bristol, said: “Some doctors use spironolactone to treat acne in women, especially in the United States, and report successful effects. However, there have hardly been any trials conducted around this, and the biggest trial to date only involved 50 participants. So, there is very little evidence to support the use of spironolactone in adult females with acne.
“If spironolactone is shown to work for acne in this large study, it will inform national and international guidelines. Results may encourage doctors to prescribe spironolactone instead of antibiotics to treat acne in women.”
The £1.7 million study was funded by the National Institute for Health Research (NIHR). Dr Miriam Santer (University of Southampton) and Dr Alison Layton (Harrogate and District NHS Foundation Trust) are leading the work, along with researchers at the Universities of Bristol (principal investigators: Dr Matthew Ridd and Dr Debbie Shipley), Cardiff, East Anglia and Nottingham. The trial is being run by Southampton Clinical Trials Unit.
Women should be aged 18 and over to take part in the study. For more information, visit: www.southampton.ac.uk/safa/index.page