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

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.

• Authors: Alexandra Poinas, Marie Lemoigne, Sarah Le Naour, Jean-Michel Nguyen, Solène Schirr-Bonnans, Valery-Pierre Riche, Florence Vrignaud, Laurent Machet, Jean-Paul Claudel, Marie-Thérèse Leccia, Ewa Hainaut, Nathalie Beneton, Cécile Dert, Aurélie Boisrobert, Laurent Flet, Anne Chiffoleau, Stéphane Corvec, Amir Khammari, Brigitte Dréno
• Journal: Trials (Trials) Vol. 21 Issue 1 Pg. 571 (Jun 25 2020) ISSN: 1745-6215 [Electronic] England
• PMID: 32586344 (Publication Type: Clinical Trial Protocol, Journal Article)

Chemical References

• Mineralocorticoid Receptor Antagonists
• Spironolactone

Topics

• Acne Vulgaris (drug therapy)
• Administration, Cutaneous
• Adult
• Clinical Trials, Phase III as Topic
• Double-Blind Method
• Female
• France
• Humans
• Mineralocorticoid Receptor Antagonists (adverse effects, therapeutic use)
• Multicenter Studies as Topic
• Randomized Controlled Trials as Topic
• Risk Factors
• Severity of Illness Index
• Spironolactone (adverse effects, therapeutic use)
• Treatment Outcome