Alopecia, Alopecia, Androgenetic, Baldness
Conditions
Brief summary
This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).
Interventions
DRUGBimatoprost
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
Exclusion criteria
* History of Paget's disease, osteoporosis, or bone malignancy * History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures * Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study * 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 * Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) | 42 Days |
| Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale | Baseline, 42 Days |
| Maximum plasma level (Cmax) of bimatoprost and its acid metabolite | 31 Days |
Countries
United States
Outcome results
None listed