Alopecia Clinical Trial
Verified date | November 2015 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).
Status | Completed |
Enrollment | 244 |
Est. completion date | January 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year - Willingness to maintain same hair style, length and hair color during study - Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only) 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 - Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study - Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs). | Baseline, Month 6 | No |
Primary | 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. | Month 6 | No |
Secondary | 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. | Month 6 | No |
Secondary | 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. | Month 6 | No |
Secondary | 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) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs). | Baseline, Month 6 | No |
Secondary | 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) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs). | Baseline, Month 6 | No |
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