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

Primary Purpose

Hypotrichosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
topical bimatoprost
Sponsored by
Kenneth Beer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotrichosis focused on measuring mild, moderate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kenneth R. Beer, M.D. ,PA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical bimatoprost for eyebrows

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2011
Last Updated
June 14, 2012
Sponsor
Kenneth Beer
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01387906
Brief Title
Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
Official Title
Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Beer
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotrichosis
Keywords
mild, moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical bimatoprost for eyebrows
Arm Type
Experimental
Arm Description
Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis).
Intervention Type
Drug
Intervention Name(s)
topical bimatoprost
Other Intervention Name(s)
bimatoprost, Latisse, eyebrows
Intervention Description
topical bimatoprost will be applied one drop to each eyebrow each night.
Primary Outcome Measure Information:
Title
Efficacy of Latisse applied to the lateral and medial eyebrow
Description
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.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Beer, M.D.
Organizational Affiliation
Beer, Kenneth R., M.D., PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kenneth R. Beer, M.D. ,PA
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20463804
Citation
Law SK. Bimatoprost in the treatment of eyelash hypotrichosis. Clin Ophthalmol. 2010 Apr 26;4:349-58. doi: 10.2147/opth.s6480.
Results Reference
background
PubMed Identifier
19478690
Citation
Bimatoprost 0.03% solution (latisse) for eyelash enhancement. Med Lett Drugs Ther. 2009 Jun 1;51(1313):43-4. No abstract available.
Results Reference
background
Links:
URL
http://www.palmbeachcosmetic.com
Description
eyebrows, bimatoprost, hypotrichosis

Learn more about this trial

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

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