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.

Spironolactone for adult female acne (SAFA): protocol for a double-blind, placebo-controlled, phase III randomised study of spironolactone as systemic therapy for acne in adult women

“…Although others are seeking to evaluate the role of spironolactone in comparison with oral tetracyclines, 37 this is the largest study to date to inform clinical practice over the effectiveness of spironolactone as an alternative treatment for acne in adult women.…”

“… †Recorded on a 6-point Likert Scale with photographs taken at the baseline visit to aid recall. 37 ‡5-point scale ranging from clear to severe (0, clear; 1, almost clear; 2, mild; 3, moderate; 4, severe). 25 §Same scale as the IGA but written in plain English for participants’ use.…”

What is new in adult acne for the last 2 years: focus on acne pathophysiology and treatments

“…Based on the recent clinical data, spironolactone seems to be safe and effective for the treatment of acne in women. Prospective studies must be conducted to further confirm the safety and efficacy of spironolactone in this population 63 …”

Progress of different treatment modalities to limit the use of antibiotics in the treatment of acne

“…FASCE and SAFA, two randomized trials, are being conducted to compare the efficacy of spironolactone over oral antibiotics. The results of these trials anticipated making the drug FDA approved [23]. Dosing is 25-200 mg/day, starting from 100 mg/day.…”