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The University of Southampton
SAFA study

Getting started

Getting started

If you are interested in taking part in the SAFA study (Spironolactone for Adult Female Acne), please read the information provided on this page.

We are currently working on reopening our study hospitals for recruitment in a phased manner. If the study hospital closest to you is not listed as ‘open for recruitment’ yet, please email safa@soton.ac.uk and we will contact you as soon as we know when the study will reopen at your local study hospital. 

For women who would like to join the study, please keep looking at the social media updates on Twitter (@SafaAcne) and Instagram (safaclinicaltrial) where we will update you as things progress. 

Brief overview of study

The SAFA study is 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. By carrying out the SAFA trial, we hope that adult women with acne might benefit in the future if this trial is successful.

Watch a short video about the SAFA study and have a look at the ‘What is SAFA?’ page to find out more about why we are running this study.

What does taking part in the study involve?

After the initial phone conversation with a member of your local research team, you will be scheduled for your first visit (in person at the clinic). Your second and third visits at 6 and 12 weeks after your first visit can be held virtually or in person. At your 12-week visit, you will receive enough study tablet supply for three months and will be asked to complete a questionnaire 6 months (24 weeks) after your first clinic visit. You will be sent a final follow-up questionnaire by post 6 months or sooner after you finished the study treatment at 24-weeks. If your visits are held virtually, the study tablets and questionnaires will be posted to you directly.

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

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.

Am I eligible?

 

Question AnswerExplanation
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.

Which hospitals are taking part in the study?

The hospitals listed below are running the SAFA study.

The tests at your first visit need to be done in person. This means you should choose the hospital that is closest to you when contacting the study team. The two appointments at 6 and 12 weeks after your first visit can take place virtually or in person.

Birmingham – Queen Elizabeth Hospital (Post code: B15 2TH) – closed for recruitment

Bristol – Royal Infirmary Dermatology Centre (Post code: BS2 8HW) – closed for recruitment

Epsom – General Hospital (Poste code: KT18 7EG) – open for recruitment

Harrogate – District Hospital (Post code: HG2 7GX) – open for recruitment

Poole – General Hospital (Post code: BH15 2JB) – closed for recruitment

Portsmouth – St Mary’s General Dermatology Centre (Post code: PO3 6AD) – open for recruitment


We are working on reopening the study hospitals for recruitment in a phased manner. If the study hospital closest to you is not listed as ‘open for recruitment’ yet, please email safa@soton.ac.uk and we will contact you as soon as we know when the study will reopen at your local study hospital.

How do I take part in the study?

If you feel the study may be suitable for you please contact our study team (safa@soton.ac.uk) and include which study hospital is closest to you.

We are working on reopening the study hospitals for recruitment in a phased manner. If the study hospital closest to you is not listed as ‘open for recruitment’ yet, please email safa@soton.ac.uk and we will contact you as soon as we know when the study will reopen at your local study hospital.

Please keep also looking at updates on Twitter (@SafaAcne) and Instagram (safaclinicaltrial).

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