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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypotrichosis
• Intervention / Treatment: Drug: topical bimatoprost

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33401
      • Kenneth R. Beer, M.D. ,PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical bimatoprost for eyebrows; Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis).	Drug: topical bimatoprost; topical bimatoprost will be applied one drop to each eyebrow each night.; Other Names: bimatoprost, Latisse, eyebrows

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Latisse applied to the lateral and medial eyebrow	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.	10 months

Collaborators and Investigators

• Sponsor: Kenneth Beer
• Collaborators: Allergan
• Investigators: Principal Investigator: Kenneth Beer, M.D., Beer, Kenneth R., M.D., PA

Publications and helpful links

General Publications

• Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010 Apr 26;4:349-58. doi: 10.2147/opth.s6480.
• Bimatoprost 0.03% solution (latisse) for eyelash enhancement. Med Lett Drugs Ther. 2009 Jun 1;51(1313):43-4. No abstract available.

Helpful Links

• eyebrows, bimatoprost, hypotrichosis

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 1, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 6, 2011

Study Record Updates

• Last Update Posted (Estimate): June 15, 2012
• Last Update Submitted That Met QC Criteria: June 14, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: moderate; mild
• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Hypotrichosis; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: Latisse2010