NDLI: FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial

Content Provider	Springer Nature : BioMed Central
Author	Poinas, Alexandra Lemoigne, Marie Le Naour, Sarah Nguyen, Jean-Michel Schirr-Bonnans, Solène Riche, Valery-Pierre Vrignaud, Florence Machet, Laurent Claudel, Jean-Paul Leccia, Marie-Thérèse Hainaut, Ewa Beneton, Nathalie Dert, Cécile Boisrobert, Aurélie Flet, Laurent Chiffoleau, Anne Corvec, Stéphane Khammari, Amir Dréno, Brigitte
Abstract	Background Acne vulgaris has increased in women over the past 10 years; it currently affects 20–30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of systemic treatment approved for female acne include cyclines (leading to bacterial resistance); zinc salts (less effective than cyclines); and antiandrogens (risks of phlebitis). The last alternative is represented by isotretinoin, but its use in women of childbearing potential is discouraged because of the teratogen risks. In this context, spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at the sebaceous gland and inhibits luteinizing hormone (LH) production at the pituitary level. It has no isotretinoin constraints and does not lead to bacterial resistance. Currently, very few studies have been performed in a limited number of patients: the studies showed that at low doses (lower than 200 mg/day), spironolactone can be effective against acne. In that context, it is clearly of interest to perform the first double-blind randomized study of spironolactone versus cyclines, which remains the moderate acne reference treatment, and to demonstrate the superiority of spironolactone’s efficacy in order to establish it as an alternative to cyclines. Methods Two hundred female patients will be included. They must have acne vulgaris with at least 10 inflammatory lesions and no more than 3 nodules. After randomization, the patients will be treated by spironolactone or doxycycline for 3 months and after placebo. The study will be blind for the first 6 months and open for the last 6 months. Discussion The treatment frequently used in female acne is systemic antibiotics with many courses, as it is a chronic inflammatory disease. In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. Trial registration ClinicalTrials.gov: NCT03334682. Registered on 7 November 2017.
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-020-04432-w.pdf
Ending Page	16
Page Count	16
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-020-04432-w
Journal	Trials
Issue Number	1
Volume Number	21
Language	English
Publisher	BioMed Central
Publisher Date	2020-06-25
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Acne vulgaris Spironolactone Cycline Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

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