getting-started | SAFA study | University of Southampton

Recruitment complete

The results of the SAFA trial are out! Our trial has shown evidence that spironolactone is an effective treatment for persistent acne, and a safe and readily available alternative to antibiotics.

Read the news story.

The results have been published in the British Medical Journal.

We would like to thank all the women who took part in the study and the hospital and GP research teams who made it possible.

Brief overview of study

The SAFA study was a randomised study looking at how effective a tablet called spironolactone is when taken alongside usual treatments for adult women with acne, compared with usual treatments alone.

A third of people who see their doctor for their acne are prescribed a long course of oral antibiotics (antibiotics taken by mouth). There are growing concerns about bacteria becoming resistant to antibiotics and there is a need to find new effective alternative treatments to antibiotics. Through the SAFA trial, we showed that adult women with acne may benefit from being prescribed spironolactone.

Watch a short video about the SAFA study results, and have a look at the ‘What is SAFA?’ page to find out more about the study.

We are no longer recruiting participants for this study, and the results have now been published - https://www.bmj.com/content/381/bmj-2022-074349

What did taking part in the study involve?

After an initial phone conversation with a member of a local research team, participants were scheduled for a first visit (in person at the clinic). The second and third visits at 6 and 12 weeks after the first visit could be held virtually or in person. At the 12-week visit, participants received enough study tablet supply for three months and were asked to complete a questionnaire 6 months (24 weeks) after their first clinic visit. They were sent a final follow-up questionnaire by post 6 months or sooner after they finished taking the tablets at 24-weeks. If visits were held virtually, the study tablets, vouchers and questionnaires were posted directly.

You can find detailed information of what happened at each of the visit the ‘Taking part’ page and see the Patient Information Leaflet below.

We are no longer recruiting participants for this study, and the results have now been published - https://www.bmj.com/content/381/bmj-2022-074349

What is the study tablet?

Spironolactone is part of a group of medicines called ‘potassium sparing diuretics’ or water tablets. It is usually given to people who have excess fluid in their body and helps to get rid of this extra fluid. Spironolactone also lowers some of the hormones that cause grease production. Grease production is raised in acne, so some dermatologists think that spironolactone can help treat acne.

Spironolactone is currently widely used to help with high blood pressure, heart failure, nephrotic syndrome (a kidney disorder), liver cirrhosis with fluid retention (oedema) and swelling of the abdomen. Spironolactone has been used by many dermatologists for acne, particularly in the US, but only some trials have been carried out to test its effectiveness, so spironolactone is not currently licenced for use in acne.

We hope the publication of the SAFA results will mean more GPs and dermatologists feel confident to prescribe spironolactone as a treatment for acne. Read a lined opinion piece from the SAFA Chief Investigators Professor Miriam Santer and Professor Alison Layton - "What do we know about prescribing spironolactone 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.

Am I eligible?

We are no longer recruiting participants for this study, and the results have now been published - https://www.bmj.com/content/381/bmj-2022-074349

Question	Answer	Explanation
Are you a woman aged 18 years or older?	Yes	We are looking for adult women with mild, moderate or severe facial acne (that has lasted for 6 months or more) to take part in the research study. If you have answered 'yes' to these three questions, you may be eligible and so please read on.
Have you had acne on your face for 6 months or longer?	Yes
How would you describe the acne on your face at the moment?	Some blackheads or whiteheads with a few or more red bumps, or your skin is worse than this.
Do you have hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption?	No	The study tablets contain a very small amount of lactose. Patients with these specific conditions should not take spironolactone.
Are you pregnant, breastfeeding or planning to become pregnant in the next 6 months?	No	There is a very small chance the study tablet drug could affect the way the baby develops. But risk of harm to a foetus is low and is likely to be lower than for other treatments taken by mouth for acne. Women who are pregnant, breastfeeding or planning to become pregnant should not take part in this acne research study.
Are you taking Roaccutane (by mouth), or have you taken it in the last 6 months?	No	Both Roaccutane and antibiotics can improve acne and may mask the effect of the study tablet. Please wait until you have been off Roaccutane for 6 months before contacting your local study team. Please wait until you have been off antibiotics for 1 month before contacting the local study team. If you answered 'yes' to either of these questions, please wait until you have stopped taking the medicine (for the length of the time described above) before contacting your local study team.
Are you taking antibiotics (by mouth) for your acne, or have you taken any in the last month?	No
Have you started, stopped or changed hormonal contraception/treatment in the last 3 months?	No	Hormonal contraception/treatment can improve acne and may mask the effect of the study tablet. If you answered 'yes', please wait until 3 months from starting, stopping or changing hormonal contraception/treatment before contacting your local study team.
Have you ever taken spironolactone?	No	The mechanism of spironolactone and its duration of effect is unknown. If you answered 'yes', the study is not suitable for you.

If you are eligible and you wish to take part in this acne research study, please contact safa@soton.ac.uk for more information or to book your first clinic visit.