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The University of Southampton
SAFA study

Taking part

The results of the SAFA trial are out!

The SAFA trial is now complete and we are no longer recruiting participants to the study

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.

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

Visit

1 st 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 1 st 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

(postal questionnaire)

  • 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 (or sooner)

(postal questionnaire)

  • You complete the final postal questionnaire
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