Oral Spironolactone for Adult Female Acne (SAFA): multicentre double-blind randomised trial

Conference: 
SAPC ASM 2023 - Brighton
Talk Code: 
7C.2
Presenter: 
Megan Lawrence
Co-authors: 
Megan Lawrence1, Miriam Santer2, Matthew J Ridd3, Nick Francis2, Ingrid Muller2, Susi Renz1, Zina Eminton1, Beth Stuart4, Sarah Pyne5, Tracey Sach5, Irene Soulsby6, Karen Thomas6, Jacqui Nuttall1, Gareth Griffiths1, Kim S Thomas7, Paul Little2, Alison M Layton8
Author institutions: 
1. Southampton CTU, Uni of Southampton, 2. Primary Care Research Centre, Uni of Southampton; 3. Population Health Sciences, Uni of Bristol; 4. Wolfson Institute of Population Health, Queen Mary Uni of London; 5. Health Economics Group, Uni of East Anglia; 6. Public contributor; 7. Centre of Evidence Based Dermatology, Uni of Nottingham; 8. Skin Research Centre, Uni of York

Problem

Background

Acne is a common problem that causes significant burden. Patients are frequently prescribed prolonged courses of oral antibiotics leading to increased antimicrobial resistance. Oral spironolactone is prescribed for acne however there is lack of evidence for its effectiveness.

Aim

To determine the effectiveness of oral spironolactone for acne in adult women.

 

Approach

Methods

This is a double-blind randomised superiority trial with women 18 years or older with facial acne for at least 6 months, judged to warrant oral antibiotics. Participants were identified through primary and secondary healthcare and through community and social media advertising. Participants were randomised 1:1 to either 50mg/day spironolactone or matched placebo until week-6, increasing to 100mg/day spironolactone or placebo until week-24. Topical treatment use could be continued.

The primary outcome was the Acne-Specific Quality of Life (Acne-QoL) symptom subscale score at week-12 (range 0 to 30, where higher scores reflect improved QoL). Secondary outcomes included Acne-QoL at week-24, participant self-assessed improvement, Investigator’s Global Assessment (IGA) and adverse effects.

 

Findings

Results

Of the 1267 women that were assessed for eligibility, 410 were randomised (201 intervention, 209 control) and 342 were included in the primary analysis. The mean age at baseline was 29.2 years (sd 7.2) and 7.9% (28/356) were from a non-white background. 46% of participants had mild acne, 40% moderate and 13% severe. Topical treatments were used by 83% (340/410). Over 95% in both groups tolerated treatment and increased dosage.

The mean Acne-QoL symptom scores at baseline and week-12 for spironolactone were 13.2 (sd 4.9) and 19.2 (sd 6.1) and for placebo were 12.9 (sd 4.5) and 17.8 (sd 5.6) respectively (difference favouring spironolactone 1.27 (95%CI 0.07 to 2.46), adjusted for baseline variables). At week-24 the scores for spironolactone were 21.2 (sd 5.9) and for placebo were 17.4 (sd 5.8) (difference 3.45 (95%CI 2.16 to 4.75) adjusted).

Secondary outcomes also favoured spironolactone at week-12 with greater differences at week-24. More participants reported acne improvement on spironolactone compared to those on placebo. This difference was not statistically significant at week-12 (72.2% vs 67.9% (OR 1.16 (95%CI 0.70 to 1.91), adjusted)) but it was significant at week-24 (81.9% vs 63.3% (OR 2.72 (95%CI 1.50 to 4.93), adjusted)). Treatment success (IGA-classified) at week-12 was 31/168 (18.5%) on spironolactone and 9/160 (5.6%) on placebo (OR 5.18 (95%CI 2.18 to 12.28)).

Adverse reactions were not serious and were similar between groups, but more headaches were reported on spironolactone (20.4% vs 12.0%).

Consequences

Conclusions

Spironolactone improved acne outcomes compared to placebo, with greater differences at week-24 than week-12. This study supports spironolactone as a useful alternative to oral antibiotics for adult women with persistent acne.

 

Submitted by: 
Megan Lawrence
Funding acknowledgement: 
This trial is primarily funded by the NIHR Health Technology Assessment Programme 16/13/02