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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

Tracking Information
First Submitted Date  ICMJE July 1, 2011
First Posted Date  ICMJE July 6, 2011
Last Update Posted Date June 15, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01387906 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Latisse (Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
Official Title  ICMJE Latisse(Bimatoprost .03% Opthalmic Solution) for the Treatment of Hypotrichosis of the Eyebrows: Latisse Versus Placebo
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypotrichosis
Intervention  ICMJE Drug: topical bimatoprost
topical bimatoprost will be applied one drop to each eyebrow each night.
Other Name: bimatoprost, Latisse, eyebrows
Study Arms  ICMJE Experimental: Topical bimatoprost for eyebrows
Topical bimatoprost will be applied to areas of the eyebrow that have diminished eyebrows (hypotrichosis).
Intervention: Drug: topical bimatoprost
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2011)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01387906
Other Study ID Numbers  ICMJE Latisse2010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Beer, Beer, Kenneth R., M.D., PA
Study Sponsor  ICMJE Kenneth Beer
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Kenneth Beer, M.D. Beer, Kenneth R., M.D., PA
PRS Account Beer, Kenneth R., M.D., PA
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP