Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

Androgenetic Alopecia Clinical Trial

Official title:

Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170662
• Other study ID #: Pro00017573
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2014
• Last updated: August 27, 2014
• Start date: November 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Androgenetic Alopecia
• Male Pattern Hair Loss

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percent Change in the Target Area Terminal Hair Count	Terminal hairs are those which grow beyond a cm and contribute to overall hair density.	Baseline to week 17; and week 17 to week 34	No
Secondary	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	Baseline to week 17; and week 17 to week 34	No
Secondary	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.	Baseline to week 17; Week 17 to week 34	No