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Southampton Clinical Trials Unit News

Non-antibiotic oral treatment for acne proven to be effective

Published: 17 May 2023
Kelly Cornick
SAFA participant Kelly Cornick, before and after taking part in the trial

A team of researchers led from Southampton has shown that a cheap and readily available drug, used to treat high blood pressure, could help the thousands of women who suffer from persistent acne.

The SAFA study, funded by the National Institute for Health and Care Research (NIHR), is the first large-scale clinical trial to provide evidence that spironolactone is an effective treatment for the skin condition.

The results of the trial, led by GP Professor Miriam Santer from the University of Southampton and Dermatologist Professor Alison Layton from Harrogate and District NHS Foundation Trust and the Skin Research Centre at the University of York, and run by the Southampton Clinical Trials Unit, have been published in the British Medical Journal today (17th May).

It’s expected the results will change in the way acne in women is routinely treated, improve acne outcomes, and reduce the large amount of antibiotics currently prescribed for the condition.

A need for new treatments

Acne is very common, particularly in adolescence, and often clears with age. But almost a third of women continue to be affected in adulthood and 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, but if they don’t work then 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 over 18, with acne that had persisted for more than 6 months and where oral antibiotics would have normally been the next treatment. Half were randomly allocated to take spironolactone, while the other half were given a placebo, or dummy pill.

The women were asked to complete questionnaires on their acne and quality of life relating to the condition at the start of the trial and then at 12 and 24 weeks into their treatment.

“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,” says Professor Miriam Santer, GP and co-lead of the trial.

“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.”

Making a real difference

Kelly Cornick, 39, began suffering with severe acne in her teens and since then has been prescribed various creams and antibiotics as well as 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 both physically but also psychologically.

“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 said: ‘have you got chicken pox’. 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 was told about the SAFA trial by 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 the antibiotics. I want people to be able to experience it, because everyone should feel confident and happy, and not have spots.”

Positive results

Zina Eminton, Senior Trial Manager at the Southampton Clinical Trials Unit 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 and agile in the way the trial was run, using social media to help recruit participants and conducting follow-up appointments virtually over video calls. Seeing these positive results published today is a fantastic achievement for everyone involved and we believe 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 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.”

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, and we hope this trial will lead to a change in the UK guidelines.”

The SAFA trial was run by the Southampton Clinical Trials Unit. It was funded by a Health Technology Assessment grant from the National Institute for Health and Care Research (NIHR) and was sponsored by the University of Southampton.

You can read the full article inn the British Medical Journal .

Notes for editors

The Southampton Clinical Trials Unit (SCTU) is a National institute for Health and Care Research (NIHR) supported and Cancer Research UK (CRUK) core-funded CTU with expertise in the design, conduct and analysis of interventional, multi-centre clinical trials. The CTU is based within the University of Southampton with offices at the University Hospital Southampton NHS Foundation Trust Southampton General Hospital site. For more information, visit the SCTU website .

The University of Southampton (UoS) drives original thinking, turns knowledge into action and impact, and creates solutions to the world’s challenges. We are among the top 100 institutions globally (QS World University Rankings 2023). Our academics are leaders in their fields, forging links with high-profile international businesses and organisations, and inspiring a 22,000-strong community of exceptional students, from over 135 countries worldwide. Through our high-quality education, the University helps students on a journey of discovery to realise their potential and join our global network of over 200,000 alumni.

Harrogate and District NHS Foundation Trust cares for the population in Harrogate and the local area as well as across North Yorkshire and Leeds. The trust provides 0-19 children’s services in the North East in County Durham, Darlington, Middlesbrough, Stockton-on-Tees, Gateshead and Sunderland. The hospital has an active and enthusiastic Research and Innovation department and is committed to delivering research in order to support opportunities for the public to have access to the latest high quality research studies and to ensure care is provided in line with the latest evidence.

About the National Institute for Health and Care Research

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

·         Funding high quality, timely research that benefits the NHS, public health and social care;

·         Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;

·         Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;

·         Attracting, training and supporting the best researchers to tackle complex health and social care challenges;

·         Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;

·         Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.

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