Efficacy, tolerability, and safety of montelukast versus finasteride for the treatment of moderate acne in women: A prospective, randomized, single-blinded, active-controlled trial.

Abstract

Acne is a chronic inflammatory skin disease which involves the pilosebaceous unit. Tissue inflammation isone of the crucial mechanisms, amongst others. Of the various cytokines, leukotriene B4 (LT-B4) is the most potentleucocyte chemotactic mediator. Montelukast is an antagonist of the LT-B4 receptor. Finasteride is an antiandrogen whichspecifically inhibits the 5α-reductase enzyme. This study aimed at comparing the efficacy, tolerability and safety of montelukast versus finasteride in the treatmentof moderate acne in women. This randomized, single-blinded, prospective trial over 12weeks recruited 65 female subjects with moderate acne vulgaris (Global Acne Grading System Scale) for evaluation. One group (n=30) received oral montelukast (10mg PO daily), while the second group (n=25) received oral finasteride (2.5mg PO daily) in combination with topical clindamycin 2% solution. Lesion count and acne severity were evaluated at time intervals of 0 (baseline), 4, 8, and 12weeks. Adverse effects of the drugs were noted. Both lesion count and severity of acne decreased significantly after treatment in both the groups as compared to the baseline. The acne severity score reached from 33.93 in time zero to 20.6 in the 12th week and 35.71 at baseline to 16.43 at the end of treatment in the Montelukast and Finasteride groups, respectively. Side effects were noted in 3 patients and 2 patients in the monteleukast and finasteride group, respectively, which were transient and non-serious in nature proving the satisfactory tolerability and safety of these two drugs. The results of this study show that both montelukast and finasteride have good efficacy in the treatment of acne. Finasteride has more efficacy than montelukast for treating moderate acne in normo-androgenic women.