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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kenneth Beer
• Collaborator: Allergan
• Treatments: Bimatoprost

Criteria

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