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Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

Primary Purpose

Male Pattern Hair Loss, Androgenetic Alopecia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bimatoprost
Placebo
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Pattern Hair Loss focused on measuring male pattern hair loss, androgenetic alopecia, bimatoprost

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA.
  2. Subject's hair color must have adequate contrast against scalp color to allow hair counting on macrophotography.
  3. Good health with normal blood tests for hematological, renal, and liver function.
  4. Able to return to Duke for study visits.

Exclusion Criteria:

  1. ECOG >1.
  2. Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12 months or oral dutasteride in the past 24 months.
  3. Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6 months and any in the past month.
  4. Taken any chemotherapy in the past 2 years.
  5. Used any over-the-counter (OTC) preparation that purports to help hair growth in the past four months.
  6. Used prostaglandins of any type in the past or currently.
  7. Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair transplants, or scalp reductions.
  8. Any skin abnormalities in the target area that would effect hair growth.
  9. Any history of glaucoma or elevated intraocular pressure (IOP).
  10. Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must be in remission.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Active drug

    Placebo

    Arm Description

    During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.

    During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.

    Outcomes

    Primary Outcome Measures

    Percent Change in Target Area Total Hair Count
    The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.

    Secondary Outcome Measures

    Percent Change in the Target Area Terminal Hair Count
    Terminal hairs are those which grow beyond a cm and contribute to overall hair density.
    Percent Change in the Target Area Vellus Hair Count
    Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness
    Percent Change in Hair Diameter
    The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.

    Full Information

    First Posted
    June 20, 2014
    Last Updated
    August 27, 2014
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02170662
    Brief Title
    Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
    Official Title
    Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine the effect of bimatoprost solution on scalp hair growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is not approved for the treatment of scalp hair loss and its use in this study is considered investigational which means it is still being tested in research studies. Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Male Pattern Hair Loss, Androgenetic Alopecia
    Keywords
    male pattern hair loss, androgenetic alopecia, bimatoprost

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active drug
    Arm Type
    Active Comparator
    Arm Description
    During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.
    Arm Title
    Placebo
    Arm Type
    Active Comparator
    Arm Description
    During Part I of the study, subjects will be randomized in a blinded fashion to either placebo (vehicle that does not contain active drug) or topical bimatoprost to apply to the scalp target area every day for 16 weeks. After a 10 day washout period, each group will be crossed over to the alternate topical preparation (Part II) to apply for 16 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Bimatoprost
    Intervention Description
    Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Percent Change in Target Area Total Hair Count
    Description
    The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.
    Time Frame
    Baseline to week 17; and week 17 to week 34
    Secondary Outcome Measure Information:
    Title
    Percent Change in the Target Area Terminal Hair Count
    Description
    Terminal hairs are those which grow beyond a cm and contribute to overall hair density.
    Time Frame
    Baseline to week 17; and week 17 to week 34
    Title
    Percent Change in the Target Area Vellus Hair Count
    Description
    Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of <40 um. They are increased in number in male pattern baldness
    Time Frame
    Baseline to week 17; and week 17 to week 34
    Title
    Percent Change in Hair Diameter
    Description
    The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.
    Time Frame
    Baseline to week 17; Week 17 to week 34

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA. Subject's hair color must have adequate contrast against scalp color to allow hair counting on macrophotography. Good health with normal blood tests for hematological, renal, and liver function. Able to return to Duke for study visits. Exclusion Criteria: ECOG >1. Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12 months or oral dutasteride in the past 24 months. Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6 months and any in the past month. Taken any chemotherapy in the past 2 years. Used any over-the-counter (OTC) preparation that purports to help hair growth in the past four months. Used prostaglandins of any type in the past or currently. Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair transplants, or scalp reductions. Any skin abnormalities in the target area that would effect hair growth. Any history of glaucoma or elevated intraocular pressure (IOP). Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must be in remission.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elise Olsen, MD
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

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