Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

NCT02170662 | Completed Phase 2 Results

• 1 other identifier: Pro00017573
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Male Pattern Hair Loss; Androgenetic Alopecia

Keywords

male pattern hair loss; androgenetic alopecia; bimatoprost

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to week 17; and week 17 to week 34

Secondary Outcomes (3)

• Percent Change in the Target Area Terminal Hair Count

  Baseline to week 17; and week 17 to week 34

• Percent Change in the Target Area Vellus Hair Count

  Baseline to week 17; and week 17 to week 34

• Percent Change in Hair Diameter

  Baseline to week 17; Week 17 to week 34

Study Arms (2)

Active drug

ACTIVE COMPARATOR

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; Drug: Placebo

Placebo

ACTIVE COMPARATOR

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; Drug: Placebo

Interventions

Bimatoprost DRUG

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

Active drug; Placebo

Placebo DRUG

Active drug; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Alopecia

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Dr. Elise Olsen
• Organization: Duke University Medical Center

elise.olsen@dm.duke.edu

919-668-5613

Study Officials

• Elise Olsen, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: November 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 5, 2014
• Results First Posted: August 20, 2014

Record last verified: 2014-07