Flutamide versus a cyproterone acetate-ethinyl estradiol combination in moderate acne: a pilot randomized clinical trial

Abstract

BackgroundThe use of oral flutamide is rarely investigated in acne therapy. The aim of this study was to compare the efficacy of oral flutamide with that of a cyproterone-estradiol combination in treating acne lesions.MethodsA randomized clinical trial enrolled patients with moderate acne into two equal groups to receive either oral flutamide or the cyproterone-estradiol combination for 6 months. Lesion count, Acne Severity Index, and Global Acne Grading system (GAGS) scores were used to assess improvement in acne lesions. The dichotomous measurement scale for primary endpoint assessment was defined as improvement from moderate to mild acne based on GAGS score. Patient satisfaction and dermal fat were also assessed. Intention to treat and per protocol analyses were done, reporting related effect sizes.ResultsBoth treatments resulted in substantial improvement in acne lesions. Although flutamide seemed to have higher efficacy, an intention to treat analysis did not find the two treatment protocols to be different. The relative risk in intention to treat analysis was 1.8 (95% confidence interval [CI] 0.89–1.6), and was 1.33 (95% CI 1.03–1.72) for the per protocol analysis. The number needed to treat for flutamide compared with the cyproterone-estradiol combination was 7.7 and 4.2 in the intention to treat and per protocol analyses, respectively.ConclusionFlutamide appears to be more effective than a cyproterone-estradiol combination in some aspects of acne treatment, but this requires confirmation in a larger trial.

Physicochemical Properties and Anti-Propionibacterium acnes Activity of Film-Forming Solutions Containing Alpha-Mangostin-Rich Extract

“…Acne appears in skin areas rich in pilosebaceous units, i.e., face, back, and trunk (3). It is attributed to many factors including androgen activity, increase in sebum production, follicular hyperkeratinization, change in sebum lipid quality, and proliferation of Propionibacterium acnes within the follicles (4).…”

Is hormonal treatment still an option in acne today?

“…Its effectiveness in the treatment of acne, hirsutism and androgenetic alopecia has been demonstrated . Of nine studies identified for this review, only one specifically studied the effect of flutamide on acne; the primary focus of the other studies was on hirsutism but all studies found at least a marked improvement in acne compared with baseline and/or placebo and/or comparator products …”

“…The standard dose used in acne ranges between 62·5 and 500 mg daily, which can result in an 80% improvement of acne. Flutamide can be used alone or in combination with metformin and COCs in patients with PCOS . Hepatic toxicity is the major limitation of this drug and it seems to be dose‐ and age‐related; it is advised to use a low initial dose and subsequently increase it.…”

Recent Advances in Acne Pathogenesis: Implications for Therapy

“…Spironolactone, which has dual function through androgen receptor blockade and inhibition of 5a-reductase, can reduce sebum production and improve acne [73,74]. Flutamide (FDA-approved for the treatment of prostate cancer) is a non-steroidal androgen receptor blocker that has also been effective, but cost and hepatotoxicity significantly limit its use [75]. Outside of the USA, clinicians can prescribe anti-androgen cyproterone acetate at low dosage (2 mg/day) or higher dosage (50 mg/day) combined with estrogen; of note, patients on higher-dosage cyproterone acetate should be monitored for hepatotoxicity.…”