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

Last updated: June 14, 2012
Sponsor: Kenneth Beer
Overall Status: Completed

Phase

4

Condition

Alopecia

Hair Loss

Treatment

N/A

Clinical Study ID

NCT01387906
Latisse2010
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 atBaseline 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 glabellaregion).

  • Able to understand the requirements of the study and sign Informed Consent/HIPAAAuthorization forms.

  • Written informed consent and written authorization for use or release of health andresearch information obtained.

  • Willing to complete all required study visits, procedures, and evaluations includingphotography.

Exclusion

Exclusion Criteria:

  • Subjects who are pregnant (positive urine pregnancy test), planning to becomepregnant, breast-feeding, or who are of childbearing potential and not practicing areliable method of birth control.

  • Patients with any uncontrolled systemic disease

  • Patient with any known disease or abnormality of the eyebrows including eczema andseborrheic 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 (includingLumigan)

  • Patients with a known hypersensitivity to bimatoprost or any other ingredient inLatisse

  • 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 theeyebrows

  • Participation in another investigational drug or device study within the last 30 days

Study Design

Total Participants: 20
Study Start date:
March 01, 2011
Estimated Completion Date:
June 30, 2012

Connect with a study center

  • Kenneth R. Beer, M.D. ,PA

    West Palm Beach, Florida 33401
    United States

    Site Not Available

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