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Completed

NCT Number: NCT02170662

Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

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.

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Key information

Conditions

Male Pattern Hair Loss Alopecia Androgenetic Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bimatoprost

Drug

Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.

Placebo

Drug

Primary outcomes

  1. Percent Change in Target Area Total Hair Count

    Time frame: Baseline to week 17; and week 17 to week 34

    The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.

Secondary outcomes

  1. Percent Change in the Target Area Terminal Hair Count

    Time frame: Baseline to week 17; and week 17 to week 34

    Terminal hairs are those which grow beyond a cm and contribute to overall hair density.

  2. Percent Change in the Target Area Vellus Hair Count

    Time frame: Baseline to week 17; and week 17 to week 34

    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

  3. Percent Change in Hair Diameter

    Time frame: Baseline to week 17; Week 17 to week 34

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 23, 2014
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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