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Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Male Pattern Hair Loss
Androgenetic Alopecia
Interventions Drug: Bimatoprost
Drug: Placebo
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Then Bimatoprost Bimatoprost Then Placebo
Hide 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
Arm/Group Title Placebo Then Bimatoprost Bimatoprost Then Placebo Total
Hide 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 Number of Baseline Participants 3 6 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
6
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 6 participants 9 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
6
 100.0%
9
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 6 participants 9 participants
3 6 9
1.Primary Outcome
Title Percent Change in Target Area Total Hair Count
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
intention to treat (ITT)
Arm/Group Title Placebo Then Bimatoprost Bimatoprost Then Placebo
Hide 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.

Overall Number of Participants Analyzed 3 6
Mean (Full Range)
Unit of Measure: percentage change in total hair count
Part 1: Baseline to week 17
-2.6
(-10.4 to 2.7)
27.4
(-19.8 to 112.5)
Part 2: week 17 to week 34
4.9
(-2.4 to 12.0)
-5.8
(-33.3 to 10.4)
2.Secondary Outcome
Title Percent Change in the Target Area Terminal Hair Count
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Bimatoprost Bimatoprost Then Placebo
Hide 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.

Overall Number of Participants Analyzed 3 6
Mean (Full Range)
Unit of Measure: percent change of terminal hair count
Part 1: Baseline to week 17
-2.1
(-9.8 to 10.1)
12.1
(-18.7 to 32.5)
Part 2: week 17 to week 34
-5.1
(-22.7 to 8.2)
-8.3
(-25.0 to 14.1)
3.Secondary Outcome
Title Percent Change in the Target Area Vellus Hair Count
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Then Bimatoprost Bimatoprost Then Placebo
Hide 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.

Overall Number of Participants Analyzed 3 6
Mean (Full Range)
Unit of Measure: Percent change of vellus hair count
Part 1: Baseline to week 17;
-2.6
(-16.7 to 17.6)
78.1
(-45.9 to 406.0)
Part 2: week 17 to week 34
5.1
(-10.0 to 19.3)
2.9
(-43.3 to 34.0)
4.Secondary Outcome
Title Percent Change in Hair Diameter
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed, and therefore not reported.
Arm/Group Title Placebo Then Bimatoprost Bimatoprost Then Placebo
Hide 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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Then Bimatoprost Bimatoprost Then Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Then Bimatoprost Bimatoprost Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Then Bimatoprost Bimatoprost Then Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/9 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Elise Olsen
Organization: Duke University Medical Center
Phone: 919-668-5613
EMail: elise.olsen@dm.duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02170662    
Other Study ID Numbers: Pro00017573
First Submitted: June 20, 2014
First Posted: June 23, 2014
Results First Submitted: July 31, 2014
Results First Posted: August 20, 2014
Last Update Posted: September 5, 2014