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The University of Southampton
SAFA study

Taking part

SAFA during Covid-19

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.  

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.

 

Visit  

 1st clinic visit

at study hospital

  • 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 visit

(virtual appointment)

  • A doctor will assess how your acne has responded to treatment
  • You bring back the tablet bottle
  • You complete a postal 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 visit

(virtual appointment/clinic visit)

  • A doctor will assess how your acne has responded to treatment
  • You bring back the tablet bottle
  • You complete a postal 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 postal 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 postal questionnaire
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Page 9 of 9_Patient Information Leaflet

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