Bimatoprost 0.03% Solution for the Treatment of Nonfacial Vitiligo.
BACKGROUND
Topical prostaglandin E2has shown efficacy in patients with localized, stable vitiligo. Bimatoprost is a synthetic prostamide (prostaglandin-ethanolamides) F2a analog. Bimatoprost 0.03% ophthalmic solution showed efficacy in the treatment of vitiligo in one small study.<br />


OBJECTIVE
To assess the efficacy and safety of bimatoprost 0.03% alone and in combination with a topical steroid (mometasone) compared with mometasone alone in patients with nonsegmental vitiligo on nonfacial areas in a proof-of-concept study.<br />


METHODS
This randomized, double-blind, controlled study was conducted over a 20-week treatment period. Patients were randomized to 1 of 3 treatment groups: bimatoprost monotherapy (n=11), bimatoprost plus mometasone (n=10), and mometasone plus placebo (n=11). The primary outcome was global response at week 20, based on an investigator's assessment of improvement score of at least 5 (at least 50%-75% improvement from baseline) on an 8-point scale (0=worse; 7=cleared). Other outcomes included global response at other visits, response by anatomic site, change from baseline lesion severity (overall and by site), and safety.<br />


RESULTS
Because of a lack of response observed for the primary end point, a post hoc analysis with a less stringent definition of response (score of &ge;4 [25%-50% improvement]) was conducted. In this analysis, 46% of the bimatoprost plus mometasone group responded overall compared with 18% in the bimatoprost monotherapy group, and no patients in the mometasone plus placebo group. Greater response rates were observed in both bimatoprost groups compared with the mometasone plus placebo group starting at week 12. There were no differences among groups in signs and symptoms of irritation.<br />


CONCLUSIONS
Bimatoprost alone or with mometasone provided greater repigmentation than treatment with mometasone alone. Larger studies that also assess facial lesions are warranted.<br /><br /> <em>J Drugs Dermatol</em>. 2016;15(6):703-710.
Pearl E
PE
Grimes
D000328:Adult; D000069580:Bimatoprost / Q000008:administration & dosage*; D004311:Double-Blind Method; D004339:Drug Compounding; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D000068656:Mometasone Furoate / Q000008:administration & dosage; D019999:Pharmaceutical Solutions / Q000008:administration & dosage; D012880:Skin Pigmentation / Q000187:drug effects*; D016896:Treatment Outcome; D014820:Vitiligo / Q000175:diagnosis* / Q000188:drug therapy*
D019999:Pharmaceutical Solutions; D000068656:Mometasone Furoate; D000069580:Bimatoprost