Spironolactone for Adult Female Acne
Research type
Research Study
Full title
Spironolactone for Adult Female Acne: A pragmatic multicentre double-blind randomised superiority trial to investigate the clinical and cost-effectiveness of spironolactone for moderate or severe persistent acne in women
IRAS ID
246637
Contact name
Miriam Santer
Contact email
Sponsor organisation
University of Southampton
Eudract number
2018-003630-33
ISRCTN Number
ISRCTN12892056
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
Summary of Research
Acne is very common and often continues into adulthood where impact on quality of life can be significant. Creams (topical treatments) can be effective but these may not be helpful and treatment taken by mouth (oral treatment), such as antibiotics (most commonly used), the contraceptive pill or co-cyprindiol (hormonal treatment) may be required. These are slow to work and not recommended for use over long periods of time. In addition, concerns about antibiotic resistance mean we need alternatives. \n\nSpironolactone reduces hormones called androgens, which increase grease production and cause changes in follicles in the skin making them prone to acne. This study will measure whether spironolactone helps adult women with persistent acne that would normally be treated with oral antibiotics. \n\nWomen aged 18 years and over will be randomly allocated to one of two groups. In addition to standard care, women will take either spironolactone tablets or placebo (dummy pill) once a day for 24 weeks. During the first 12 weeks, participants may continue using topical treatments as usual but not oral treatments for acne (with the exception of the contraceptive pill if they are already using it and have been on it for 3 months or more). The study will run for 52 weeks, but participants will be able to use all other treatments as usual after the first 24 weeks (apart from oral antibiotics, which may be used from 12 weeks onwards). \n\nAfter 24 weeks all participants and their GPs will be informed which tablets the participant received in the study. Participants in both arms may ask their GP to prescribe it. \n\nWe will assess the result of the study by asking participants to complete a standardised questionnaire about acne.\n
Summary of Results
What was the question?
Acne (or spots) is common and often persists into adulthood. Many people take long courses of antibiotic tablets but concerns about antibiotic resistance mean alternatives are needed. Spironolactone is a medicine that is sometimes used for acne in women. However, we do not know whether it works. This trial aimed to answer this question.
What did we do?
We invited women aged over 18 who had acne on their face for at least 6 months to take part via their GP surgery, hospital or advertising. Women were randomly assigned to two groups: one group was given spironolactone and the other group was given identical-looking placebo (“dummy pill”) daily for 24 weeks. Women in both groups could continue using acne treatments applied to the skin (gels/creams/lotions). We asked participants to rate their acne using a questionnaire called Acne-QoL, asked whether they felt their skin had improved and asked skin specialists to assess their skin.
What did we find?
410 women took part, many of whom had had acne for a long time. Acne-QoL scores improved in both groups by 12 weeks, but improved more in the spironolactone group at 12 and 24 weeks.
When asked directly whether their skin had improved, 71% of participants in the spironolactone group said it had, compared with 43% on placebo. Skin specialists were also more likely to report the acne had improved in the spironolactone group.
Side effects were mild and similar in both groups but there were slightly more headaches on spironolactone (20% compared with 12%).
Spironolactone is likely to represent value for money for the NHS, though this depends on a number of factors including what it is compared to.
What does this mean?
This trial suggests that spironolactone is a useful additional treatment for women with persistent acne.REC name
Wales REC 3
REC reference
18/WA/0420
Date of REC Opinion
10 Jan 2019
REC opinion
Further Information Favourable Opinion