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.

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Key information

Conditions

Hypotrichosis Hair Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kenneth R. Beer, M.D. ,PA

West Palm Beach, Florida, 33401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

topical bimatoprost

Drug

topical bimatoprost will be applied one drop to each eyebrow each night.

Other names: bimatoprost, Latisse, eyebrows

Primary outcomes

Efficacy of Latisse applied to the lateral and medial eyebrow

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kenneth Beer

Indiv

Collaborators

Allergan

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jul 6, 2011
Registry last updated: Jun 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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