Trial Outcomes & Findings for Treatment of Androgenetic Alopecia in Females, 9 Beam (NCT NCT00981461)

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

Baseline, 16 weeks, 26 weeks

Results posted on

2012-08-10

Participant Flow

This double-blind, device controlled 26 week study was recruited at 6 clinical study sites. The recruitment period was from October 29, 2008 to March 2, 2009

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

Participant milestones
Measure	HairMax LaserComb 2009 9 Beam This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.	Control Device This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
Overall Study STARTED	48	24
Overall Study COMPLETED	43	22
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	HairMax LaserComb 2009 9 Beam This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.	Control Device This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
Overall Study Lost to Follow-up	5	2

Baseline Characteristics

Treatment of Androgenetic Alopecia in Females, 9 Beam

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HairMax LaserComb 2009 9 Beam n=43 Participants This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner	Control Device n=22 Participants This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis.	Total n=65 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	43 Participants n=5 Participants	22 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	22 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 16 weeks, 26 weeks

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.

Outcome measures

Outcome measures
Measure	Control Device n=22 Participants This control device is inactive emitting white light	HairMax LaserComb 2009 9 Beam n=43 Participants This device is the active device with 9 laser modules
Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline Change at 16 weeks	1.3 hairs per cm^2 Standard Deviation 14.67	14.8 hairs per cm^2 Standard Deviation 9.70
Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline Change at 26 weeks	2.8 hairs per cm^2 Standard Deviation 16.48	20.2 hairs per cm^2 Standard Deviation 11.15

Adverse Events

Control Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HairMax LaserComb 2009 9 Beam

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

David Michaels

Lexington International, LLC

Phone: 5614170200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place