A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
- Conditions
- AlopeciaAlopecia, AndrogeneticBaldness
- Interventions
- Registration Number
- NCT01904721
- Lead Sponsor
- Allergan
- Brief Summary
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 244
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 1: Bimatoprost Solution 1 Twice Daily Bimatoprost Solution 1 Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Stage 1: Bimatoprost Solution 1 Once Daily Bimatoprost Solution 1 Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 1: Bimatoprost Solution 1 Once Daily Bimatoprost Vehicle Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 1: Bimatoprost Solution 2 Once Daily Bimatoprost Solution 2 Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 1: Bimatoprost Solution 2 Twice Daily Bimatoprost Solution 2 Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. Stage 1: Bimatoprost Solution 2 Once Daily Bimatoprost Vehicle Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. Stage 2: Bimatoprost Solution 1 Twice Daily Bimatoprost Solution 1 Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Stage 2: Bimatoprost Solution 2 Twice Daily Bimatoprost Solution 2 Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. Stage 2: Bimatoprost Vehicle Twice Daily Bimatoprost Vehicle Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
- Primary Outcome Measures
Name Time Method Change From Baseline in Target Area Hair Count (TAHC) Baseline, Month 6 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).
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score Month 6 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
Name Time Method Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score Month 6 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 Month 6 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) Baseline, Month 6 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).
Change From Baseline in Target Area Hair Darkness (TAHD) Baseline, Month 6 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).