Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo

Study Overview
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Brief Summary
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The primary purpose of this study is to assess efficacy and safety of Latisse (bimatoprost .03% ophthalmic solution) applied to the lateral and medial eyebrows. The primary outcome is a increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period.

Official Title
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Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo

Conditions
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Hypotrichosis

Intervention / Treatment
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* Drug: topical bimatoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient, female/male subjects of any race, 18-75 years of age. Subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study Patients with hypotrichosis (thinning) of the eyebrows with a GEyA score of 1 or 2. Patient agrees to abstain from any treatment to the eyebrows including: waxing, plucking, threading, laser hair removal, and/or bleaching (excluding the glabella region). Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Written informed consent and written authorization for use or release of health and research information obtained. Willing to complete all required study visits, procedures, and evaluations including photography. Exclusion Criteria: Subjects who are pregnant (positive urine pregnancy test), planning to become pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control. Patients with any uncontrolled systemic disease Patient with any known disease or abnormality of the eyebrows including eczema and seborrheic dermatitis Patients with known or suspected trichotillomania disorder Patients with a history of glaucoma and/or increased ocular pressure Patients who are currently using an IOP-lowering prostaglandin analog (including Lumigan) Patients with a known hypersensitivity to bimatoprost or any other ingredient in Latisse Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.). Patients with permanent eye and/or eyebrow make-up Any eyebrow tint or dye applications within 2 months prior to study entry Any planned facial cosmetic procedure that would interfere with the evaluation of the eyebrows Participation in another investigational drug or device study within the last 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical bimatoprost for eyebrows<br>Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis). | Drug: topical bimatoprost<br>* topical bimatoprost will be applied one drop to each eyebrow each night.<br>* Other names: bimatoprost, Latisse, eyebrows;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Latisse applied to the lateral and medial eyebrow | Increase in overall eyebrow prominence as measured by at least a 1-grade increase on the Global Eyebrow Assessment (GEyA) scale, from baseline to the end of the treatment which will be day 270 period. | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild, moderate