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Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects.

ABSTRACT: OBJECTIVE:To evaluate long-term efficacy and safety of bimatoprost for treatment of chemotherapy-induced eyelash hypotrichosis. DESIGN:One-year, multicenter, double-masked, parallel-group study. SETTING:Twenty-one centers in the United States and one center in the United Kingdom. PARTICIPANTS:This study randomized (3:1) 130 subjects to bimatoprost 0.03% or vehicle applied topically to upper eyelid margins for six months. All subjects used bimatoprost for a second six months. MEASUREMENTS:Responders for the primary composite end point achieved ?1-grade improvement in Global Eyelash Assessment score and ?3-point improvement in Confidence, Attractiveness, and Professionalism domain score of the Eyelash Satisfaction Questionnaire at Month 4. Secondary assessments included eyelash length, thickness, and darkness, using digital image analysis. RESULTS:The responder rate was significantly higher with bimatoprost versus vehicle at Month 4 (37.5% vs. 18.2%; p=0.041) and Month 6 (46.9% vs. 18.2%; p=0.004). Significant improvements favoring bimatoprost occurred in eyelash length (p=0.008), thickness (p<0.001), or darkness (p=0.029) at Month 4, with similar results at Month 6 (p<0.001, length; p<0.001, thickness; p=0.002, darkness). Responder rates reached 61.5 percent at Month 12 for subjects continuing bimatoprost and 67.6 percent for those switched from vehicle to bimatoprost. Conjunctival hyperemia (16.7%) and punctate keratitis (9.4%) were the most common adverse events. CONCLUSION:Bimatoprost provides rapid eyelash recovery, whether started shortly after chemotherapy (4 to 12 weeks) or delayed for six months, with minimal adverse events. CLINICAL TRIAL REGISTRY:NCT00907426.

SUBMITTER: Wirta D

PROVIDER: S-EPMC4456802 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects.

Wirta David D Baumann Leslie L Bruce Suzanne S Ahluwalia Gurpreet G Weng Emily E Daniels Selena S

The Journal of clinical and aesthetic dermatology 20150401 4

<h4>Objective</h4>To evaluate long-term efficacy and safety of bimatoprost for treatment of chemotherapy-induced eyelash hypotrichosis.<h4>Design</h4>One-year, multicenter, double-masked, parallel-group study.<h4>Setting</h4>Twenty-one centers in the United States and one center in the United Kingdom.<h4>Participants</h4>This study randomized (3:1) 130 subjects to bimatoprost 0.03% or vehicle applied topically to upper eyelid margins for six months. All subjects used bimatoprost for a second six ...[more]

PMID: 26060513

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Project description: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 .

Dataset Information

Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects.

Publications

Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects.

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