Research Title: Spironolactone for Adult Female Acne (SAFA)

Department: Portsmouth Hospitals NHS Trust

We would like to invite you to take part in a research study. Acne is a common condition and can be distressing. Many people take long courses of antibiotics or other tablets, none of which are suitable for long-term use. Spironolactone is a non-antibiotic tablet that is widely used to treat other conditions like high blood pressure. It is sometimes used for acne as it has hormonal effects, which are thought to help. But, there is little proof it works.We are looking for women aged 18 years or over to take part in a new study to see if spironolactone really does help treat acne in women.

Volunteers must be:

  • Age: 18 years or over
  • Gender: Female
  • Staff/Student: Staff

Eligibility criteria:

  • You have facial acne, present for at least 6 months
  • Your acne is moderate or severe (some blackheads or whiteheads with a few or more red bumps, or your skin is worse than this)
  • You do not have problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption          
  • You have never taken spironolactone
  • You are not pregnant, breastfeeding or planning to become pregnant in the next 6 months
  • You have not have started, stopped or changed long-term hormonal contraception (or other hormonal treatment) in the 3 months before starting the study; and you must not start, stop or change hormonal contraception or treatment during the first 3 months of the study
  • You must not have taken antibiotics by mouth for your acne in the month before starting the study; and you must not take them during the first 3 months of the study
  • You must not have taken Roaccutane in the 6 months before the study; and you must not take it during the first 6 months of the study
  • Women who could become pregnant must be willing to use their usual hormonal or barrier method of contraception for the first 6 months of the study and for 4 weeks (about one menstrual cycle) afterwards
At your first clinic visit, one small blood sample (about 5-10ml, 1-2 teaspoons) will be taken in order to test your kidney function and blood potassium level to make sure it is safe for you to take part. Women who could become pregnant will also need to take a urine pregnancy test before entering the trial.You can continue to use your usual topical treatment (creams, gels and lotions) for your acne throughout the study. It would be helpful if you did not change your topical treatment for the first 3 months of the study.

More Information:

As a thank you for your participation, we will give you a £20 shopping voucher at your first clinic visit and a £10 shopping voucher at 6 weeks and 12 weeks.

  • Dates: Recruiting from June 2019 to November 2020
  • Duration: 12 weeks (3 clinic visits – one when you start the study, then at 6 weeks and 12 weeks) plus follow-up at week 24 and week 52 via postal questionnaire
  • Location: St Mary’s Hospital, Portsmouth

If you would like more information, contact Dermatology Research Team (St Mary's Hospital) at dermatology.research@porthosp.nhs.uk or +44(0)23 8054 0469

More information is available on the University of Southampton website.

This testing has been reviewed by the Science Faculty ethics committee and been given the following ethics code: Wales REC 3 - 18/WA/0420

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