Status:
COMPLETED
Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Thinning Eyebrows
Lead Sponsor:
ATS Clinical Research
Collaborating Sponsors:
Allergan
Conditions:
Hypotrichosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week study where Bimatopros...
Detailed Description
A parallel, placebo-controlled, single-center, prospective, randomized, double blind, pilot trial to demonstrate bimatoprost 0.03% efficacy in eyebrow hypotrichosis in otherwise healthy individuals wi...
Eligibility Criteria
Inclusion
- Females and males, ages 18-75 years with brows that are naturally thinning with a score of 1 (very thin) or 2 (thin) at baseline as determined by the Investigator Global Eyebrow Assessment (IGEA).
- Subjects who agree to forgo any additional treatment to the brows, such as waxing, plucking, threading and/or tinting for the duration of the study.
- Desires to participate in a research study
Exclusion
- Any uncontrolled systemic disease.
- Any known diseases or abnormalities to the eyelid or eyebrow.
- Known allergies or reactions to bimatoprost or placebo ingredients.
- Pregnancy.
- Subjects that have thinning brows as a result of over plucking, trichotillomania, chemotherapy or any other condition or treatment that causes hair loss.
- Subjects who have used any over the counter or prescription eyebrow growth product 3 months prior to baseline.
- Subjects with tattooed eyebrows and/or any permanent or semi-permanent tint or dye within 3 months prior to baseline.
- Subjects with a score of 3 or 4 on the eyebrow scale.
- Current enrollment in an investigational drug or device study or participation in such a study 30 days prior to baseline.
- Subjects using prostaglandin analogs for the treatment of high intraocular pressure.
- Aphakic subjects and/or pseudophakic subjects with a torn posterior lens capsule.
- Subjects with known risk factors for macular edema.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01891487
Start Date
May 1 2013
End Date
January 1 2015
Last Update
January 14 2015
Active Locations (1)
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1
Ava MD
Santa Monica, California, United States, 90404