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The University of Southampton
SAFA study

Taking part

SAFA during Covid-19

The study is currently closed to recruitment owing to Covid-29. 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. We are hoping to reopen again in a few months. In the meantime, please let us know (safa@soton.ac.uk) if you are interested in taking part in the trial once things have returned back to normal or if you have any questions or concerns.

 

What does taking part in the study involve?

If you are interested in taking part in the SAFA study, please read the Participant Information Leaflet (see download at the bottom of the page) for more information and answer a few questions to see if the study is suitable for you.

If you decide to take part in the SAFA study, please contact your nearest study centre to discuss the study with the local study team and to book you first clinic visit. 

Timeline of SAFA study
Timeline of the SAFA study and appointment schedule

To thank you for your time, you will be given a £20 shopping voucher at your first visit (because it is the longest visit, but unlikely to take longer than 90 minutes), a £10 voucher at the 6-week visit, and a £10 voucher at the 12-week visit.

 

Clinic visit  
 1st clinic visit
  • Discuss the study with a member of the local study team and ask any questions
  • You give informed consent to take part
  • A small blood sample will be taken and your kidney function tested
  • A photograph of your acne will be taken to compare your acne/spots before and after treatment
  • You complete a questionnaire about your acne, any treatments you use, and any costs associated with your health and care needs relating to acne
  • You will be allocated to one of two groups: spironolactone or placebo ('dummy pill')
  • You take the tablets once a day for six weeks

All patients can continue to use creams, gels and lotions for their acne.

 

 6-week clinic visit
  • A doctor will assess how your acne has responded to treatment
  • You bring back the tablet bottle
  • You complete a questionnaire to assess any improvement in your acne based on the photograph taken at your 1st visit
  • If you are tolerating the side effects, your dose can be increased to 2 tablets per day
 12-week clinic visit
  • A doctor will assess how your acne has responded to treatment
  • You bring back the tablet bottle
  • You complete a questionnaire to assess any improvement in your acne based on the photograph taken at your 1st visit
  • The dose might be increased (if not already taking 2 tablets/day)
  • If the treatment has not helped your skin as much as expected, your doctor might decide to try different topical treatments (creams, gels, lotions) or may prescribe you oral antibiotics to take as well
 24 weeks
  • You stop taking the study tablets
  • You complete a questionnaire about how satisfied you are with the acne treatment
  • We will send a letter to you and your GP to let you know which study tablets you were taking (spironolactone/placebo)
  • If you would like to continue/start taking spironolactone, please speak to your GP about this
  • Between 24 and 52 weeks you can ask your usual doctor for different topical treatments or oral antibiotics for your acne
 52 weeks  
  • You complete the final questionnaire

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