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Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

NCT01325337 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2014-04-10

Study results available
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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.

Conditions

  • Alopecia
  • Alopecia, Androgenetic
  • Baldness

Interventions

DRUG

bimatoprost Formulation A

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

DRUG

bimatoprost Formulation B

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

DRUG

bimatoprost Formulation C

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

DRUG

bimatoprost vehicle solution

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

DRUG

minoxidil 5% solution

Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325337 on ClinicalTrials.gov