FASCE: The Benefit of Spironolactone for Treating Acne in Women - Study Protocol for a Randomized Double-Blind Trial

    June 2020 in “ Trials ”
    Alexandra Poinas, M Lemoigne, S. Le Naour, Jean–Michel Nguyen, Solène Schirr-Bonnans, Valéry-Pierre Riche, Florence Vrignaud, L. Machet, Jean‐Paul Claudel, Marie‐Thérèse Leccia, E. Hainaut, N. Bénéton, Cécile Dert, Aurélie Boisrobert, Laurent Flet, Anne Chiffoleau, Stéphane Corvec, Amir Khammari, Brigitte Dréno
    TLDR The trial aims to test if spironolactone is an effective acne treatment for women without the side effects of current treatments.
    The FASCE trial aimed to evaluate the efficacy of spironolactone compared to doxycycline in treating acne in women through a randomized double-blind study involving approximately 200 participants. The primary objective was to determine whether spironolactone could significantly reduce acne severity compared to doxycycline, with secondary objectives including safety, quality of life, and cost-effectiveness over 12 months. The study used the Adult Female Acne Scoring Tool (AFAST) for precise evaluation and included a detailed methodology for participant selection, dosage, and assessment criteria. The trial was designed to provide an alternative to antibiotics, addressing concerns about antibiotic resistance, and to offer insights into the optimal treatment duration and efficacy of spironolactone for acne.
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