Abstract
BackgroundBimatoprost 0.03 % has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects. The studies described in this report evaluated the efficacy and safety of bimatoprost in Japanese subjects with idiopathic and chemotherapy-induced eyelash hypotrichosis.MethodsIn two multicenter, double-masked, randomized, parallel-group studies (study 1: n = 173 [idiopathic]; study 2: n = 36 [chemotherapy-induced]), subjects received bimatoprost 0.03 % or vehicle applied once daily to the upper eyelid margins. The primary efficacy measure was eyelash prominence measured by Global Eyelash Assessment (GEA) scores. Additional measures were eyelash length, thickness, and darkness, assessed by digital image analysis, and patient satisfaction (Eyelash Satisfaction Questionnaire-9). Safety assessments included adverse-event monitoring and ophthalmic examinations.ResultsSignificantly more bimatoprost-treated subjects had at least a one-grade improvement in GEA score from baseline to month 4 compared with vehicle in study 1 (77.3 vs 17.6 %; P < 0.001) and study 2 (88.9 vs 27.8 %; P < 0.001). Bimatoprost-treated subjects had significantly greater increases in eyelash length, thickness, and darkness at the primary time point (month 4 in both studies; all P < 0.001, study 1; P ≤ 0.04, study 2). The bimatoprost group showed greater subject satisfaction in both studies. The incidence of adverse events was similar in the two groups. Ophthalmic examination showed slightly greater mean reductions in intraocular pressure (IOP) with bimatoprost than with vehicle, and the reductions were within the normal range for daily IOP fluctuations.ConclusionBimatoprost 0.03 % was shown to be effective and safe in these studies of Japanese subjects with eyelash hypotrichosis.Level of Evidence IThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Highlights
Eyelashes are important in the concept of physical beauty, and many women use cosmetic approaches to obtain longer and thicker lashes [1,2,3]
The studies described in this report evaluated the efficacy and safety of bimatoprost in Japanese subjects with idiopathic and chemotherapy-induced eyelash hypotrichosis
The primary efficacy measure was eyelash prominence measured by Global Eyelash Assessment (GEA) scores
Summary
Eyelashes are important in the concept of physical beauty, and many women use cosmetic approaches to obtain longer and thicker lashes [1,2,3]. Individuals seek eyelash enhancements for a variety of reasons. Some individuals exhibit inadequate or sparse eyelashes (i.e., hypotrichosis) characterized by reduced hair growth, which may be attributed to known etiologies such as age, hereditary factors, chemotherapy, and other medical treatments, but often the etiology is unknown [5]. Hair loss, including loss of eyelashes, is common among patients undergoing chemotherapy and is considered a troubling adverse effect that can have psychosocial consequences [7, 8]. Bimatoprost 0.03 % has enhanced eyelash prominence in clinical trials enrolling mostly Caucasian subjects. The studies described in this report evaluated the efficacy and safety of bimatoprost in Japanese subjects with idiopathic and chemotherapy-induced eyelash hypotrichosis.
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