Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Allergan
- Enrollment
- 307
- Primary Endpoint
- Change From Baseline in Target Area Hair Count (TAHC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
bimatoprost Formulation A
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Intervention: bimatoprost Formulation A (Drug)
bimatoprost Formulation B
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Intervention: bimatoprost Formulation B (Drug)
bimatoprost Formulation C
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Intervention: bimatoprost Formulation C (Drug)
bimatoprost vehicle solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
Intervention: bimatoprost vehicle solution (Drug)
minoxidil 5% solution
Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
Intervention: minoxidil 5% solution (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Target Area Hair Count (TAHC)
Time Frame: 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).
Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Time Frame: Baseline, 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 Outcomes
- Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score(Baseline, Month 6)
- Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score(Baseline, Month 6)
- Change From Baseline in Target Area Hair Width (TAHW)(Baseline, Month 6)
- Change From Baseline in Target Area Hair Darkness (TAHD)(Baseline, Month 6)