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

Phase 4

Completed

• Conditions: Hypotrichosis
• Interventions: Drug: topical bimatoprost

• Registration Number: NCT01387906
• Lead Sponsor: Kenneth Beer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-06
• Primary Completion: 2012-03
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-14
• Last Update Posted: 2012-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Topical bimatoprost for eyebrows	topical bimatoprost	Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis).

Primary Outcome Measures

Name	Time	Method
Efficacy of Latisse applied to the lateral and medial eyebrow	10 months	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.

Trial Locations

Locations (1)

Kenneth R. Beer, M.D. ,PA; 🇺🇸 West Palm Beach, Florida, United States