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.