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

NCT01387906 | Completed Phase 4 DMC

• 1 other identifier: Latisse2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotrichosis

Keywords

mild; moderate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Topical bimatoprost for eyebrows

EXPERIMENTAL

Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis).

Drug: topical bimatoprost

Interventions

topical bimatoprost DRUG

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

Also known as: bimatoprost, Latisse, eyebrows

Topical bimatoprost for eyebrows

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kenneth Beer: lead
• Allergan: collaborator

Study Sites (1)

Kenneth R. Beer, M.D. ,PA

West Palm Beach, Florida, 33401, United States

Location

Related Publications (2)

• Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010 Apr 26;4:349-58. doi: 10.2147/opth.s6480.

  PMID: 20463804 BACKGROUND

• Bimatoprost 0.03% solution (latisse) for eyelash enhancement. Med Lett Drugs Ther. 2009 Jun 1;51(1313):43-4. No abstract available.

  PMID: 19478690 BACKGROUND

Related Links

• eyebrows, bimatoprost, hypotrichosis

MeSH Terms

Conditions

Hypotrichosis; Lymphoma, Follicular

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Kenneth Beer, M.D.

  Beer, Kenneth R., M.D., PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: July 1, 2011
• First Posted: July 6, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 15, 2012

Record last verified: 2012-06

Locations

US (1)