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

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ClinicalTrials.gov Identifier: NCT01387906
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : June 15, 2012
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Kenneth Beer, Beer, Kenneth R., M.D., PA

Study Description
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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
Hypotrichosis Drug: topical bimatoprost Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Loss
Drug Information available for: Bimatoprost

Arms and Interventions
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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 Name: bimatoprost, Latisse, eyebrows


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387906


Locations
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United States, Florida
Kenneth R. Beer, M.D. ,PA
West Palm Beach, Florida, United States, 33401
Sponsors and Collaborators
Kenneth Beer
Allergan
Investigators
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Principal Investigator: Kenneth Beer, M.D. Beer, Kenneth R., M.D., PA
More Information
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Additional Information:

Publications:

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Responsible Party: Kenneth Beer, Investigator, Beer, Kenneth R., M.D., PA
ClinicalTrials.gov Identifier: NCT01387906    
Other Study ID Numbers: Latisse2010
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: June 15, 2012
Last Verified: June 2012
Keywords provided by Kenneth Beer, Beer, Kenneth R., M.D., PA:
mild
moderate
Additional relevant MeSH terms:
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Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Antihypertensive Agents