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Southampton-led study identifies promising acne treatment

New research has found that a drug used to treat high blood pressure could help women with persistent acne.

SAFA is the first large-scale clinical trial to show that spironolactone is an effective treatment for the skin condition.

The results, published in the British Medical Journal, could inform routine acne treatment. This would help reduce the amount of antibiotics prescribed for the condition.

Professor Miriam Santer from the University of Southampton co-led the trial. It was run by the Southampton Clinical Trials Unit (CTU).

The research was aligned with the NIHR Southampton Biomedical Research Centre’s Microbiology, Immunology and Infection theme.

A need for new treatments

Acne is very common, particularly in adolescence, and often clears with age. But almost a third of women are still affected in adulthood. This can be a huge physical and psychological burden to those who suffer from persistent outbreaks.

Topical treatments (creams and gels), available from a pharmacy or on prescription, are the first-line treatment for acne. They are effective for many people.

If they don’t work, GPs will often prescribe oral antibiotics to be used alongside the creams and gels. This can add to the growing burden of antibiotic resistance in the population.

“For several years, dermatologists have been prescribing a drug called spironolactone to treat severe acne,” says Professor Alison Layton, consultant dermatologist and co-lead of the SAFA trial.

“This is a cheap medication which has been used for decades in the treatment of high blood pressure. The drug also reduces the main hormone that leads to the development of acne.

“However, previous studies of spironolactone for acne have been very small and there was no definitive proof that it actually worked.”

An effective treatment

The SAFA trial recruited over 400 women aged 18+. They all had persistent acne, and oral antibiotics would have been their next treatment.

Half were randomly allocated to take spironolactone. The other half were given a placebo pill.

The women completed questionnaires on their acne and quality of life at the start of the trial. They did this again when they were 12 and 24 weeks into the treatment.

“The women taking spironolactone saw a significant improvement in their acne after 12 and 24 weeks compared to those on the placebo,” says Professor Santer, GP and co-lead of the trial.

“A significantly higher proportion of people said they felt satisfied that the treatment had helped their skin. 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.”

Making a difference

Kelly Cornick, 39, began suffering with severe acne in her teens. Since then, she has been prescribed various creams, antibiotics and the contraceptive pill to try and control her skin.

“Nothing seemed to work,” says Kelly. “It might go away for a while, but then it would flare up again. It was sore, almost like blisters. I would get thick, red, lumps all along my jawline and at its worst it spread up onto the rest of my face. If I knocked a spot, it would really hurt and would bleed for ages. It was just horrible.”

The mum-of-three from Dorset says it had a huge effect on her physical and psychological health.

“It was embarrassing. People would stare and you almost feel that they’re looking at you like you’re dirty and don’t wash properly.

“I think the worst thing for me was when one of my nieces asked if I had Chickenpox. She was only about two and kids are always quite honest, but that’s how bad it looked. It used to get me down. I’m a confident person but my skin just took over how I felt a lot of the time.”

Kelly heard about the SAFA trial from her dermatologist and contacted the trial team at Poole Hospital.

“Initially I started on the lower dose and there was an improvement. I then went onto the higher dose and within about three months everything was gone, all the spots had disappeared.”

Since finishing the trial, Kelly has been able to stay on spironolactone and has now been acne-free for over two years.

“Knowing how much it’s helped me, I hope that other people will now be given this treatment as an option instead of just trying antibiotics. I want people to be able to experience it, because everyone should feel confident and happy, and not have spots.”

Encouraging results

Zina Eminton is a Senior Trial Manager at Southampton CTU. She said:

“This was a challenging trial which began just as the COVID-19 pandemic hit the UK. This meant we had to adapt to be flexible in the way the trial was run, using social media to help recruit participants and conducting virtual follow-up appointments. The results are a fantastic achievement for everyone involved and will benefit many more women in the future.”

Professor Andrew Farmer, Director of NIHR’s Health Technology Assessment Programme, said:

“The findings from this important trial provide compelling evidence which could help thousands of women with persistent acne. The treatment provides a valuable alternative to antibiotics. It 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.”

Professor Santer concludes: “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. We hope this trial will lead to a change in the UK guidelines.”

The SAFA trial was funded by a Health Technology Assessment grant from the National Institute for Health and Care Research. It was sponsored by the University of Southampton.

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