Trial Outcomes & Findings for A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy (NCT NCT01967277)
NCT ID: NCT01967277
Last Updated: 2015-05-06
Results Overview
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
baseline and 17 weeks
Results posted on
2015-05-06
Participant Flow
Participant milestones
| Measure |
Incandescent Red Light Source
Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.
|
Handi-Dome Laser
Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Incandescent Red Light Source
Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.
|
Handi-Dome Laser
Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Unrelated illness
|
0
|
1
|
Baseline Characteristics
A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
Baseline characteristics by cohort
| Measure |
Incandescent Red Light Source
n=22 Participants
Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.
|
Handi-Dome Laser
n=22 Participants
Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
49.5 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 17 weeksAt baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Outcome measures
| Measure |
Incandescent Red Light Source
n=21 Participants
Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.
|
Handi-Dome Laser
n=19 Participants
Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
|
|---|---|---|
|
Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
|
12.48 percent change
Standard Deviation 13.76
|
63.67 percent change
Standard Deviation 50.9
|
PRIMARY outcome
Timeframe: baseline and 17 weeksAt baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Outcome measures
| Measure |
Incandescent Red Light Source
n=21 Participants
Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks.
|
Handi-Dome Laser
n=19 Participants
Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks.
|
|---|---|---|
|
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Hair count, baseline
|
216.9 terminal hairs
Standard Deviation 109.1
|
189.3 terminal hairs
Standard Deviation 85.8
|
|
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Hair count, post treatment
|
235.3 terminal hairs
Standard Deviation 105.8
|
268.3 terminal hairs
Standard Deviation 117.7
|
|
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Hair count, difference
|
18.5 terminal hairs
Standard Deviation 24.4
|
89.9 terminal hairs
Standard Deviation 63.3
|
Adverse Events
Incandescent Red Light Source
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Handi-Dome Laser
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 PI may not disclose the results of the trial.
- Publication restrictions are in place
Restriction type: OTHER