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NCT02676310 Clinical Trial

Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)

Alopecia Clinical Trial

Official title:
Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02676310
Other study ID # 192024-085
Secondary ID
Status Terminated
Phase Phase 1
First received February 4, 2016
Last updated March 15, 2017
Start date March 2016
Est. completion date March 2017

Study information
Verified date March 2017
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).

Recruitment information / eligibility
Status Terminated
Enrollment 53
Est. completion date March 2017
Est. primary completion date January 2017
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

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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost

Locations
Country Name City State
United States DermResearch, LLC Austin Texas
United States J&S Studies Inc. College Station Texas
United States E&R Research Foundation Lynchburg Virginia

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) 42 Days
Primary Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale Baseline, 42 Days
Primary Maximum plasma level (Cmax) of bimatoprost and its acid metabolite 31 Days
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