Published: 18 May 2023
A cheap and readily available drug, used to treat high blood pressure, could help thousands of women who suffer from persistent acne.
The NIHR-funded SAFA study is the first large-scale clinical trial to provide evidence that spironolactone is an effective treatment for the skin condition.
The findings could change the way acne in women is routinely treated. This will improve care for patients and reduce the large amount of antibiotics prescribed for the condition. But the treatment is not suitable for men, the study team says.
Researchers at Southampton University led the trial. The results are published in the British Medical Journal (BMJ).
Acne is common in adolescence and often clears with age. But almost a third of women continue to be affected into adulthood. This can be a huge physical and psychological burden to those who suffer from persistent outbreaks.
Creams and gels available from a pharmacy or on prescription, are the first-line treatment for the condition. They are effective for many people. But if they don’t work then GPs often prescribe oral antibiotics too. This can add to the growing burden of antibiotic resistance.
For several years some dermatologists have prescribed spironolactone for severe acne. The cheap medication had been used for decades to treat high blood pressure. It also reduces the main hormone that leads to the development of acne. But until now studies investigating its effectiveness have been very small, and larger trials were needed.
A team of researchers led by the Southampton Clinical Trials Unit carried out a trial on more than 400 women aged over 18.
All the women had acne that had persisted for more than six months, where oral antibiotics would normally have been the next treatment.
Half of the participants were randomised to receive the drug. The other half received a placebo.
After 12 and 24 weeks, women who were taking the drug saw significant improvements in their acne.
Professor Miriam Santer, GP and co-lead of the trial, said: “The results showed that the women taking spironolactone saw a significant improvement in their acne after 12 and 24 weeks compared to those on the placebo.
“A significantly higher proportion of people also reported that they felt satisfied that their skin had been helped compared with those receiving placebo, and any side effects were uncommon and very minor.
“These results show that spironolactone could offer an alternative to antibiotics for many women with persistent acne to use alongside topical acne treatments.
“We hope the publication of these results will mean more GPs and dermatologists feel confident to prescribe spironolactone as a treatment for acne. The drug is already included in treatment guidelines for persistent acne in the US and Europe, and we hope this trial will lead to a change in the UK guidelines.”
Professor Andrew Farmer, Director of NIHR’s Health Technology Assessment (HTA) Programme, which funded the research, said: “The findings from this important trial provide compelling evidence which could help thousands of women affected by persistent acne. The treatment provides a valuable alternative to antibiotics and ensures clinicians can also better avoid the harms that can arise from antimicrobial resistance.
“High quality, independently funded research like this is crucial in providing evidence to improve health and social care practice and treatments.”
Researchers from Harrogate and District NHS Foundation Trust and the Skin Research Centre at the University of York were also involved in the trial.
The team embraced innovative ways to recruit participants after the COVID-19 pandemic struck . This included recruiting via social media and conducting follow-up appointments over video calls.