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

Kenneth Beer

Status and phase

Completed

Phase 4

Conditions

Hypotrichosis

Treatments

Drug: topical bimatoprost

Study type

Interventional

Funder types

Industry

Identifiers

NCT01387906

Latisse2010

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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