Trial Outcomes & Findings for Topical Bimatoprost Effect on Androgen Dependent Hair Follicles (NCT NCT02170662)
NCT ID: NCT02170662
Last Updated: 2014-09-05
Results Overview
The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Baseline to week 17; and week 17 to week 34
Results posted on
2014-09-05
Participant Flow
Participant milestones
| Measure |
Placebo Then Bimatoprost
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.
|
Bimatoprost Then Placebo
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 Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Bimatoprost Effect on Androgen Dependent Hair Follicles
Baseline characteristics by cohort
| Measure |
Placebo Then Bimatoprost
n=3 Participants
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.
|
Bimatoprost Then Placebo
n=6 Participants
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
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 17; and week 17 to week 34Population: intention to treat (ITT)
The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.
Outcome measures
| Measure |
Placebo Then Bimatoprost
n=3 Participants
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.
|
Bimatoprost Then Placebo
n=6 Participants
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.
|
|---|---|---|
|
Percent Change in Target Area Total Hair Count
Part 1: Baseline to week 17
|
-2.6 percentage change in total hair count
Interval -10.4 to 2.7
|
27.4 percentage change in total hair count
Interval -19.8 to 112.5
|
|
Percent Change in Target Area Total Hair Count
Part 2: week 17 to week 34
|
4.9 percentage change in total hair count
Interval -2.4 to 12.0
|
-5.8 percentage change in total hair count
Interval -33.3 to 10.4
|
SECONDARY outcome
Timeframe: Baseline to week 17; and week 17 to week 34Terminal hairs are those which grow beyond a cm and contribute to overall hair density.
Outcome measures
| Measure |
Placebo Then Bimatoprost
n=3 Participants
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.
|
Bimatoprost Then Placebo
n=6 Participants
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.
|
|---|---|---|
|
Percent Change in the Target Area Terminal Hair Count
Part 1: Baseline to week 17
|
-2.1 percent change of terminal hair count
Interval -9.8 to 10.1
|
12.1 percent change of terminal hair count
Interval -18.7 to 32.5
|
|
Percent Change in the Target Area Terminal Hair Count
Part 2: week 17 to week 34
|
-5.1 percent change of terminal hair count
Interval -22.7 to 8.2
|
-8.3 percent change of terminal hair count
Interval -25.0 to 14.1
|
SECONDARY outcome
Timeframe: Baseline to week 17; and week 17 to week 34Vellus 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
Outcome measures
| Measure |
Placebo Then Bimatoprost
n=3 Participants
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.
|
Bimatoprost Then Placebo
n=6 Participants
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.
|
|---|---|---|
|
Percent Change in the Target Area Vellus Hair Count
Part 1: Baseline to week 17;
|
-2.6 Percent change of vellus hair count
Interval -16.7 to 17.6
|
78.1 Percent change of vellus hair count
Interval -45.9 to 406.0
|
|
Percent Change in the Target Area Vellus Hair Count
Part 2: week 17 to week 34
|
5.1 Percent change of vellus hair count
Interval -10.0 to 19.3
|
2.9 Percent change of vellus hair count
Interval -43.3 to 34.0
|
SECONDARY outcome
Timeframe: Baseline to week 17; Week 17 to week 34Population: Data not analyzed, and therefore not reported.
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.
Outcome measures
Outcome data not reported
Adverse Events
Placebo Then Bimatoprost
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bimatoprost Then Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place