Long-term safety and efficacy of bimatoprost solution 0.03% application to the eyelid margin for the treatment of idiopathic and chemotherapy-induced eyelash hypotrichosis: a randomised controlled trial

Glaser, D.A., Hossain, Parwez, Perkins, W., Griffiths, T., Ahluwalia, G., Weng, E. and Beddingfield, F.C. (2015) Long-term safety and efficacy of bimatoprost solution 0.03% application to the eyelid margin for the treatment of idiopathic and chemotherapy-induced eyelash hypotrichosis: a randomised controlled trial. British Journal of Dermatology. (doi:10.1111/bjd.13443). (PMID:25296533)

Abstract

BACKGROUND: Bimatoprost ophthalmic solution 0.03% is approved in several countries for treating eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis.

OBJECTIVE: Evaluate long-term safety and efficacy of bimatoprost among subjects with idiopathic or chemotherapy-induced hypotrichosis.

METHODS: This multicentre, double-masked, randomised, parallel-group study included two 6-month treatment periods. Subjects with idiopathic hypotrichosis were randomised to 3 treatment groups: 1) treatment period 1 (TP1) and TP2: bimatoprost; 2) TP1: bimatoprost; TP2: vehicle; and 3) TP1: vehicle; TP2: bimatoprost. Subjects with chemotherapy-induced hypotrichosis were randomised to 2 treatment groups: 1) TP1: bimatoprost or vehicle; and 2) TP2: bimatoprost. The primary endpoint was a composite of at least a 1-grade improvement in investigator-assessed Global Eyelash Assessment (GEA), and at least a 3-point improvement in subject-reported Eyelash Satisfaction Questionnaire (ESQ) Domain 2 (self-perceived confidence, attractiveness, and professionalism) at month 4. Secondary measures included digitally assessed eyelash characteristics (ie, eyelash length, fullness, and darkness).

RESULTS: The study randomised 368 subjects. The primary efficacy endpoint was met in both populations (responder rates: idiopathic: 40.2% bimatoprost vs 6.8% vehicle; post-chemotherapy: 37.5% bimatoprost vs 18.2% vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (post-chemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4 to 6 months following treatment cessation in subjects with idiopathic hypotrichosis. No drug-related serious adverse events were reported.

CONCLUSIONS: Daily treatment with bimatoprost ophthalmic solution 0.03% for 1 year was effective and well tolerated in subjects with idiopathic and chemotherapy-induced hypotrichosis.

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Contributors

Author: Parwez Hossain

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