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

Sponsor
Kenneth Beer (Other)
Overall Status
Completed
CT.gov ID
NCT01387906
Collaborator
Allergan (Industry)
20
Enrollment
1
Location
1
Arm
15
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: topical bimatoprost
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Mar 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kenneth R. Beer, M.D. ,PA West Palm Beach Florida United States 33401

    Sponsors and Collaborators

    • Kenneth Beer
    • Allergan

    Investigators

    • Principal Investigator: Kenneth Beer, M.D., Beer, Kenneth R., M.D., PA

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Kenneth Beer, Investigator, Beer, Kenneth R., M.D., PA
    ClinicalTrials.gov Identifier:
    NCT01387906
    Other Study ID Numbers:
    • Latisse2010
    First Posted:
    Jul 6, 2011
    Last Update Posted:
    Jun 15, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Kenneth Beer, Investigator, Beer, Kenneth R., M.D., PA
    mild
    moderate
    Additional relevant MeSH terms:
    Hypotrichosis
    Bimatoprost

    Study Results

    No Results Posted as of Jun 15, 2012