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Santer, Miriam, Lawrence, Megan, Pyne, Sarah 
ORCID: https://orcid.org/0000-0003-0093-9125, Renz, Susanne, Stuart, Beth, Sach, Tracey ORCID: https://orcid.org/0000-0002-8098-9220, Ridd, Matthew, Thomas, Kim, Nuttall, Jacqueline, Permyakova, Natalia, Eminton, Zina, Francis, Nick, Little, Paul, Muller, Ingrid, Soulsby, Irene, Thomas, Karen, Griffiths, Gareth and Layton, Alison M.
(2024)
Clinical and cost-effectiveness of spironolactone in treating persistent facial acne in women: SAFA double-blinded RCT.
Health Technology Assessment, 28 (56).
ISSN 1366-5278
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Abstract
Background: Acne is common, can cause significant impact on quality of life and is a frequent reason for long-term antibiotic use. Spironolactone has been prescribed for acne in women for many years, but robust evidence is lacking. Objective: To evaluate whether spironolactone is clinically effective and cost-effective in treating acne in women. Design: Pragmatic, parallel, double-blind, randomised superiority trial. Setting: Primary and secondary healthcare and community settings (community and social media advertising). Participants: Women aged 18 years and older with facial acne persisting for at least 6 months, judged to potentially warrant oral antibiotic treatment. Interventions: Participants were randomised 1 : 1, using an independent web-based procedure, to either 50 mg/day spironolactone or matched placebo until week 6, increasing to 100 mg/day spironolactone or matched placebo until week 24. Participants continued usual topical treatment. Main outcome measures: Primary outcome was the adjusted mean difference in Acne-Specific Quality of Life symptom subscale score at 12 weeks. Secondary outcomes included Acne-Specific Quality of Life total and subscales; participant self-assessed improvement; Investigator’s Global Assessment; Participant’s Global Assessment; satisfaction; adverse effects and cost-effectiveness. Results: Of 1267 women assessed for eligibility, 410 were randomised (201 intervention, 209 control), 342 in the primary analysis (176 intervention, 166 control). Mean age was 29.2 years (standard deviation 7.2) and 7.9% (28/356) were from non-white backgrounds. At baseline, Investigator’s Global Assessment classified acne as mild in 46%, moderate in 40% and severe in 13%. At baseline, 82.9% were using topical treatments. Over 95% of participants in both groups tolerated the treatment and increased their dose. Mean baseline Acne-Specific Quality of Life symptom subscale was 13.0 (standard deviation 4.7) across both groups. Mean scores at week 12 were 19.2 (standard deviation 6.1) for spironolactone and 17.8 (standard deviation 5.6) for placebo [difference favouring spironolactone 1.27 (95% confidence interval 0.07 to 2.46) adjusting for baseline variables]. Mean scores at week 24 were 21.2 (standard deviation 5.9) in spironolactone group and 17.4 (standard deviation 5.8) in placebo group [adjusted difference 3.77 (95% confidence interval 2.50 to 5.03) adjusted]. Secondary outcomes also favoured spironolactone at 12 weeks with greater differences at 24 weeks. Participants taking spironolactone were more likely than those taking placebo to report overall acne improvement at 12 weeks {72.2% vs. 67.9% [adjusted odds ratio 1.16 (95% confidence interval 0.70 to 1.91)]} and at 24 weeks {81.9% vs. 63.3% [adjusted odds ratio 2.72 (95% confidence interval 1.50 to 4.93)]}. Investigator’s Global Assessment was judged successful at week 12 for 31/201 (18.5%) taking spironolactone and 9/209 (5.6%) taking placebo [adjusted odds ratio 5.18 (95% confidence interval 2.18 to 12.28)]. Satisfaction with treatment improved in 70.6% of participants taking spironolactone compared with 43.1% taking placebo [adjusted odds ratio 3.12 (95% confidence interval 1.80 to 5.41)]. Adverse reactions were similar between groups, but headaches were reported more commonly on spironolactone (20.4% vs. 12.0%). No serious adverse reactions were reported. Taking account for missing data through multiple imputation gave an incremental cost per quality-adjusted life-year of £27,879 (adjusted) compared to placebo or £2683 per quality-adjusted life-year compared to oral antibiotics. Conclusions: Spironolactone resulted in better participant-reported and investigator-reported outcomes than placebo, with greater differences at week 24 than week 12. Trial registration: This trial is registered as ISRCTN12892056 and EudraCT (2018-003630-33).
| Item Type: | Article |
|---|---|
| Additional Information: | Data sharing statement: Pseudonymised individual participant data (IPD) within the clinical study data set will be available for sharing via controlled access by authorised Southampton CTU staff (as delegated to Southampton CTU by the study sponsor). Data access can be requested via a Southampton CTU Data Release application form (available from www.southampton.ac.uk/ctu/about/index.page) after the trial is published. Please e-mail the completed form to the Southampton CTU Data Release Committee Co-ordinator at ctu@soton.ac.uk. Data access requests are reviewed against specific eligibility criteria by the Southampton CTU data custodian and key members of the study team, including a statistician and chief investigator or by an external Independent Review Panel. Decisions about requests are made promptly and usually no more than 3 months after receipt of request. Responses to all data requests, with a clear rationale for any refusals, will be sent promptly to the data requester. Any other queries should be addressed to the corresponding author for consideration. Funding information: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/13/02) and is published in full in Health Technology Assessment; Vol. 28, No. 56. See the NIHR Funding and Awards website for further award information. |
| Uncontrolled Keywords: | health policy,sdg 3 - good health and well-being ,/dk/atira/pure/subjectarea/asjc/2700/2719 |
| Faculty \ School: | Faculty of Medicine and Health Sciences > Norwich Medical School |
| UEA Research Groups: | Faculty of Medicine and Health Sciences > Research Groups > Health Economics Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit |
| Related URLs: | |
| Depositing User: | LivePure Connector |
| Date Deposited: | 13 Dec 2024 01:39 |
| Last Modified: | 17 Dec 2024 01:42 |
| URI: | https://ueaeprints.uea.ac.uk/id/eprint/97983 |
| DOI: | 10.3310/MYJT6804 |
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