Overview

Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Thinning Eyebrows

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
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 Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects eyebrow for duration of the study.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
ATS Clinical Research
Collaborator:
Allergan
Treatments:
Bimatoprost
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.