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Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

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ClinicalTrials.gov Identifier: NCT02170662
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 20, 2014
Last Update Posted : September 5, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
Male Pattern Hair Loss Androgenetic Alopecia Drug: Bimatoprost Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
Study Start Date : November 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Arm Intervention/treatment
Active Comparator: Active drug
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.
Drug: Bimatoprost
Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.

Drug: Placebo
Active Comparator: Placebo
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.
Drug: Bimatoprost
Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.

Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170662


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Elise Olsen, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02170662     History of Changes
Other Study ID Numbers: Pro00017573
First Posted: June 23, 2014    Key Record Dates
Results First Posted: August 20, 2014
Last Update Posted: September 5, 2014
Last Verified: July 2014

Keywords provided by Duke University:
male pattern hair loss
androgenetic alopecia
bimatoprost

Additional relevant MeSH terms:
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Hair Diseases
Alopecia
Alopecia Areata
Hypotrichosis
Skin Diseases
Pathological Conditions, Anatomical
Androgens
Bimatoprost
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antihypertensive Agents