Back to resultsSafety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Primary Purpose
Alopecia, Alopecia, Androgenetic, Baldness
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bimatoprost Formulation A
bimatoprost Formulation B
bimatoprost Formulation C
bimatoprost vehicle solution
minoxidil 5% solution
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
- Willingness to have micro-dot-tattoo applied to scalp
- Willingness to maintain same hair style, length and hair color during study
Exclusion Criteria:
- Drug or alcohol abuse within 12 months
- HIV positive
- Received hair transplants or had scalp reductions
- Use of hair weaves, hair extensions or wigs within 3 months
- Oral or topical minoxidil treatment within 6 months
- Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Arm Label
bimatoprost Formulation A
bimatoprost Formulation B
bimatoprost Formulation C
bimatoprost vehicle solution
minoxidil 5% solution
Arm Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Outcomes
Primary Outcome Measures
Change From Baseline in Target Area Hair Count (TAHC)
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Secondary Outcome Measures
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Change From Baseline in Target Area Hair Width (TAHW)
Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).
Change From Baseline in Target Area Hair Darkness (TAHD)
Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01325337
Brief Title
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Alopecia, Androgenetic, Baldness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bimatoprost Formulation A
Arm Type
Experimental
Arm Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Arm Title
bimatoprost Formulation B
Arm Type
Experimental
Arm Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Arm Title
bimatoprost Formulation C
Arm Type
Experimental
Arm Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Arm Title
bimatoprost vehicle solution
Arm Type
Placebo Comparator
Arm Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Arm Title
minoxidil 5% solution
Arm Type
Active Comparator
Arm Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost Formulation A
Intervention Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost Formulation B
Intervention Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost Formulation C
Intervention Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
bimatoprost vehicle solution
Intervention Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
minoxidil 5% solution
Other Intervention Name(s)
Rogaine®, Regaine®
Intervention Description
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Primary Outcome Measure Information:
Title
Change From Baseline in Target Area Hair Count (TAHC)
Description
TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs).
Time Frame
Baseline, Month 6
Title
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Description
The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Description
The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time Frame
Baseline, Month 6
Title
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Description
At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Target Area Hair Width (TAHW)
Description
Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs).
Time Frame
Baseline, Month 6
Title
Change From Baseline in Target Area Hair Darkness (TAHD)
Description
Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs).
Time Frame
Baseline, Month 6
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
Willingness to have micro-dot-tattoo applied to scalp
Willingness to maintain same hair style, length and hair color during study
Exclusion Criteria:
Drug or alcohol abuse within 12 months
HIV positive
Received hair transplants or had scalp reductions
Use of hair weaves, hair extensions or wigs within 3 months
Oral or topical minoxidil treatment within 6 months
Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Portland
State/Province
Oregon
Country
United States
City
Berlin
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
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