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

Authors

  • Brigitte Dréno Nantes Université, INSERM, CNRS, Immunology and New Concepts in ImmunoTherapy, INCIT, UMR 1302/EMR6001, Nantes, France
  • Jean-Michel Nguyen Department of Epidemiology and Biostatistics, CHU Nantes, Nantes, France
  • Ewa Hainaut Department of Dermatology, Poitiers University Hospital, Poitiers, France
  • Laurent Machet Department of Dermatology, CHU Tours, INSERM U1253, University of Tours, Tours, France
  • Marie-Thérèse Leccia Department of Dermatology, Allergology and Photobiology, CHU A. Michallon, Grenoble, France
  • Nathalie Beneton Department of Dermatology, Le Mans Hospital, Le Mans, France
  • Jean-Paul Claudel Private Practice, Tours, France
  • Philippe Célérier Department of Dermatology, CHR La Rochelle, La Rochelle, France
  • Marie Le Moigne Department of Dermatology, Nantes University, CHU Nantes, CIC1413, Nantes, France
  • Sarah Le Naour Department of Dermatology, Nantes University, CHU Nantes, CIC1413, Nantes, France
  • Florence Vrignaud Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France; Nantes University, CHU Nantes, UTCG, Nantes, France
  • Alexandra Poinas Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France
  • Cécile Dert Health Economics Studies and Development of Health Products, Department of Partnership and Innovation, CHU Nantes, Nantes University, Nantes, France
  • Aurélie Boisrobert Department of Dermatology, Nantes University, CHU Nantes, CIC1413, Nantes, France
  • Laurent Flet Department of Pharmacy, CHU Nantes, Nantes University, Nantes, France
  • Simon Korner Vigilances Unit, Department of Research and Innovation, CHU Nantes, Nantes University, Nantes, France
  • Amir Khammari Nantes Université, INSERM, CNRS, Immunology and New Concepts in ImmunoTherapy, INCIT, UMR 1302/EMR6001, Nantes, France; Department of Dermatology, Nantes University, CHU Nantes, CIC1413, Nantes, France

DOI:

https://doi.org/10.2340/actadv.v104.26002

Keywords:

acne, spironolactone, adult female acne, AFAST, doxycycline, quality of life

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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Published

2024-02-21

How to Cite

Dréno, B., Nguyen, J.-M., Hainaut, E., Machet, L., Leccia, M.-T., Beneton, N., … Khammari, A. (2024). 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. Acta Dermato-Venereologica, 104, adv26002. https://doi.org/10.2340/actadv.v104.26002