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

Sponsor
Allergan (Industry)
Overall Status
Terminated
CT.gov ID
NCT02676310
Collaborator
(none)
53
Enrollment
3
Locations
5
Arms
12
Duration (Months)
17.7
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [42 Days]

    2. Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale [Baseline, 42 Days]

    3. Maximum plasma level (Cmax) of bimatoprost and its acid metabolite [31 Days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DermResearch, LLC Austin Texas United States 78759
    2 J&S Studies Inc. College Station Texas United States 77845
    3 E&R Research Foundation Lynchburg Virginia United States 24501

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT02676310
    Other Study ID Numbers:
    • 192024-085
    First Posted:
    Feb 8, 2016
    Last Update Posted:
    Mar 17, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Alopecia
    Alopecia Areata
    Bimatoprost

    Study Results

    No Results Posted as of Mar 17, 2017