Bimatoprost for the Treatment of Eyebrow Hypotrichosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01765764
First received: January 9, 2013
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).


Condition Intervention Phase
Eyebrow Hypotrichosis
Drug: bimatoprost solution
Drug: Vehicle to bimatoprost solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants with at Least a 1-grade Increase (improvement) in the 4-point Global Eyebrow Assessment (GEBA) Scale [ Time Frame: Baseline, Month 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) [ Time Frame: Baseline, Month 7 ] [ Designated as safety issue: No ]
  • Change from Baseline in Eyebrow Darkness as Measured Using DMSIA [ Time Frame: Baseline, Month 7 ] [ Designated as safety issue: No ]
  • Percentage of Participants with 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]

Enrollment: 357
Study Start Date: March 2013
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bimatoprost Solution BID
Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
Drug: bimatoprost solution
Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
Experimental: Bimatoprost Solution QD
Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
Drug: bimatoprost solution
Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
Drug: Vehicle to bimatoprost solution
Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.
Placebo Comparator: Vehicle to Bimatoprost Solution BID
Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
Drug: Vehicle to bimatoprost solution
Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Mild to moderate eyebrow hypotrichosis (inadequate eyebrows)

Exclusion Criteria:

  • Patients with disease, infection, or abnormality of the eyebrow area
  • Patients with permanent eyebrow loss due to over-grooming
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765764

Locations
United States, Texas
Houston, Texas, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01765764     History of Changes
Other Study ID Numbers: 192024-043
Study First Received: January 9, 2013
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Pharmaceutical Solutions
Bimatoprost
Cloprostenol
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014