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

March 15, 2017 updated by: Allergan

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch, LLC
      • College Station, Texas, United States, 77845
        • J&S Studies Inc.
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • E&R Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Bimatoprost 0.3% (Formulation B)
0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Names:
  • Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Experimental: Cohort 2: Bimatoprost 1% (Formulation A)
0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Names:
  • Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Experimental: Cohort 2: Bimatoprost 1% (Formulation B)
0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Names:
  • Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Experimental: Cohort 3: Bimatoprost 1% (Formulation B)
1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Names:
  • Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Experimental: Cohort 4: Bimatoprost 3% (Formulation B)
1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Names:
  • Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 4, 2016

First Posted (Estimate)

February 8, 2016

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192024-085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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