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Randomized Controlled Trial
. 2024 Feb 21:104:adv26002.
doi: 10.2340/actadv.v104.26002.

Efficacy of Spironolactone Compared with Doxycycline in Moderate Acne in Adult Females: Results of the Multicentre, Controlled, Randomized, Double-blind Prospective and Parallel Female Acne Spironolactone vs doxyCycline Efficacy (FASCE) Study

Brigitte Dréno  1 , Jean-Michel Nguyen  2 , Ewa Hainaut  3 , Laurent Machet  4 , Marie-Thérèse Leccia  5 , Nathalie Beneton  6 , Jean-Paul Claudel  7 , Philippe Célérier  8 , Marie Le Moigne  9 , Sarah Le Naour  9 , Florence Vrignaud  10 , Alexandra Poinas  11 , Cécile Dert  12 , Aurélie Boisrobert  9 , Laurent Flet  13 , Simon Korner  14 , Amir Khammari  15
Affiliations
Randomized Controlled Trial

Efficacy of Spironolactone Compared with Doxycycline in Moderate Acne in Adult Females: Results of the Multicentre, Controlled, Randomized, Double-blind Prospective and Parallel Female Acne Spironolactone vs doxyCycline Efficacy (FASCE) Study

Brigitte Dréno et al. Acta Derm Venereol. .

Abstract

Acne in adult females is triggered mainly by hormones. Doxycycline is a reference treatment in acne. Spironolactone targets the androgen receptor of sebaceous glands and is prescribed off-label for female adult acne. This multicentre, controlled, randomized, double-blind prospective and parallel study assessed the efficacy of spironolactone compared with doxycycline in adult female acne. A total of 133 women with moderate acne were randomized to receive treatment with: (i) doxycycline and benzoyl peroxide for 3 months followed by a 3-month treatment with its placebo and benzoyl peroxide, or (ii) spironolactone and benzoyl peroxide for 6 months. Successfully treated patients continued with benzoyl peroxide or spironolactone alone for a further 6 months. Primary endpoints were treatment success at month 4 and month 6 with the AFAST score. At all visits, the ECLA score, lesion counts, local and systemic safety and quality of life were assessed. Spironolactone performed better at month 4 and showed a statistically significant better treatment success after 6 months than doxycycline (p = 0.007). Spironolactone was 1.37-times and 2.87-times more successful compared with doxycycline at respective time-points. AFAST and ECLA scores, as well as lesion counts always improved more with spironolactone. Patients' quality of life was better with spironolactone at month 4 and month 6. Spironolactone was very well tolerated. This is the first study to show that, in female adults with moderate acne, treatment with spironolactone is significantly more successful than doxycycline and very well tolerated.

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Conflict of interest statement

The authors have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Study design. M: month.
Fig. 2
Fig. 2
Patient disposition. ITT: Intent-to-treat; PP: per protocol ; Excl: excluded.
Fig. 3
Fig. 3
Treatment success at Month 4 and Month 6 according to contraceptive means and overall. (a) Treatment success at Month 4. (b) Treatment success at Month 6.
Fig. 4
Fig. 4
Evolution of the Adult Female Acne SCoring Tool (AFAST) score. (a) Global AFAST score, (b) AFAST 1 (Global Evaluation of Acne; GEA) score and (c) AFAST 2 (submandibular) score. *Evaluation of treatment outcome (success or failure).
Fig. 5
Fig. 5
Evolution of the Échelle de Cotation des Lésions d’Acné or. Acne Lesion Score Scale (ECLA) score over time. *Evaluation of treatment outcome (success or failure).
Fig. 6
Fig. 6
Evolution of lesion count over time. (a) Inflammatory lesion count, (b) non-inflammatory lesion count. *Evaluation of treatment outcome (success or failure).
Fig. 7
Fig. 7
Evolution of Cardiff Acne Disability Index (CADI) score over time. *Evaluation of treatment outcome (success or failure).
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