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: January 16, 2015
Last verified: January 2015
  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 ]
    The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported.


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 ]
    Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement).

  • Change From Baseline in Eyebrow Darkness as Measured Using DMSIA [ Time Frame: Baseline, Month 7 ] [ Designated as safety issue: No ]
    Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement).

  • 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 ]
    ESS Item #6 measured the participant's satisfaction with eyebrow treatment: "Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now?" using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported.


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:

-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).

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
Results First Received: January 16, 2015
Last Updated: January 16, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 26, 2015