Trial Outcomes & Findings for Treatment of Androgenetic Alopecia in Females, 12 Beam (NCT NCT01016964)
NCT ID: NCT01016964
Last Updated: 2012-09-07
Results Overview
The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.
COMPLETED
NA
63 participants
Baseline, 16 weeks, 26 weeks
2012-09-07
Participant Flow
This double-blind, device controlled 26 week study was recruited at 3 clinical study sites. The recruitment period was from February 1, 2010 to September 28, 2010
Key exclusion criteria was pregnancy, malignancy in target area, an no hair transplants, scalp reductions, or hair weaves. Active hair loss less than 12 months.
Participant milestones
| Measure |
Sham Device
Sham device
|
LLT Device 2009 12 Beams
HairMax LaserComb 2009 model 12 beam
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
42
|
|
Overall Study
COMPLETED
|
18
|
39
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Sham Device
Sham device
|
LLT Device 2009 12 Beams
HairMax LaserComb 2009 model 12 beam
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
Baseline Characteristics
Treatment of Androgenetic Alopecia in Females, 12 Beam
Baseline characteristics by cohort
| Measure |
Sham Device
n=21 Participants
Sham device
|
LLT Device 2009 12 Beams
n=42 Participants
HairMax LaserComb 2009 model 12 beam
|
Total
n=63 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
|
21 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
63 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
|
21 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 weeks, 26 weeksThe primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.
Outcome measures
| Measure |
Sham Device
n=18 Participants
This control device emits white light
|
LLT Device 2009 12 Beams
n=39 Participants
This is the active LLLT device
|
|---|---|---|
|
Change in Hair Count at 16 and 26 Weeks Over Baseline
Change at 16 weeks
|
-0.8 hairs per cm^2
Standard Deviation 7.87
|
12.5 hairs per cm^2
Standard Deviation 11.35
|
|
Change in Hair Count at 16 and 26 Weeks Over Baseline
Change at 26 weeks
|
3.0 hairs per cm^2
Standard Deviation 9.33
|
20.6 hairs per cm^2
Standard Deviation 11.55
|
Adverse Events
Sham Device
LLT Device 2009 12 Beams
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