Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02170662
• Collaborator: (none)
• Enrollment: 33
• Arms: 2
• Duration (Months): 17.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Male Pattern Hair Loss; Androgenetic Alopecia	Drug: Bimatoprost; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• 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: Nov 1, 2009
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percent Change in Target Area Total Hair Count [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Elise Olsen, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02170662
• Other Study ID Numbers: Pro00017573
• First Posted: Jun 23, 2014
• Last Update Posted: Sep 5, 2014
• Last Verified: Jul 1, 2014

• Keywords provided by Duke University: male pattern hair loss; androgenetic alopecia; bimatoprost
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Bimatoprost

Study Results

Participant Flow

Arm/Group Title	Placebo Then Bimatoprost	Bimatoprost Then Placebo
Arm/Group Description	Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.	Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks.
Period Title: Overall Study
STARTED	3	6
COMPLETED	3	6
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Placebo Then Bimatoprost	Bimatoprost Then Placebo	Total
Arm/Group Description	Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.	Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks.	Total of all reporting groups
Overall Participants	3	6	9
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 100%	6 100%	9 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	3 100%	6 100%	9 100%
Region of Enrollment (participants) [Number]
United States	3 100%	6 100%	9 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

intention to treat (ITT)

Arm/Group Title	Placebo Then Bimatoprost	Bimatoprost Then Placebo
Arm/Group Description	Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.	Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks.
Measure Participants	3	6
Part 1: Baseline to week 17	-2.6	27.4
Part 2: week 17 to week 34	4.9	-5.8

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Bimatoprost	Bimatoprost Then Placebo
Arm/Group Description	Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.	Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks.
Measure Participants	3	6
Part 1: Baseline to week 17	-2.1	12.1
Part 2: week 17 to week 34	-5.1	-8.3

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Then Bimatoprost	Bimatoprost Then Placebo
Arm/Group Description	Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.	Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks.
Measure Participants	3	6
Part 1: Baseline to week 17;	-2.6	78.1
Part 2: week 17 to week 34	5.1	2.9

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Data not analyzed, and therefore not reported.

Arm/Group Title	Placebo Then Bimatoprost	Bimatoprost Then Placebo
Arm/Group Description	Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.	Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks.
Measure Participants	0	0

Adverse Events

Arm/Group Title	Placebo Then Bimatoprost		Bimatoprost Then Placebo
Arm/Group Description	Part 1: Patients initially were randomized to apply placebo topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.		Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. Between Part 1 and Part 2 subjects completed a 10 day washout period. Part 2: Patients were randomized to apply placebo topically for 16 weeks.
All Cause Mortality
	Placebo Then Bimatoprost		Bimatoprost Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Then Bimatoprost		Bimatoprost Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Then Bimatoprost		Bimatoprost Then Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.