Trial Outcomes & Findings for Treatment of Androgenic Alopecia in Males (NCT NCT00947219)

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

79 participants

Primary outcome timeframe

baseline, 16 and 26 weeks

Results posted on

2013-01-31

Participant Flow

Male subjects who have been diagnosed with androgenetic alopicia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types i-IV and Norwood Hamilton Classifications of IIa to IV and have active hair loss with the last 12 months

Exclusion criteria: Individuals with photosensitivity to laser light, history of any malignancy in target area, has used phytotherapy (e.g. saw palmetto) with 8 weeks prior to baseline. Subjects who has chronic dermatological conditions (eczema, psoriasis, etc) of the scalp other than male pattern baldness

Participant milestones

Participant milestones
Measure	HairMax LaserComb 2009, 12 Beam LLLT Device 2009 12 Beam, Control Device	HairMax LaserComb 2009 9 Beam LLLT Device 2009 9 Beam, Control Device	Control Device Control device emitting LED light
Overall Study STARTED	28	25	26
Overall Study COMPLETED	22	21	22
Overall Study NOT COMPLETED	6	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Androgenic Alopecia in Males

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HairMax LaserComb 2009, 12 Beam n=28 Participants LLLT Device 2009 12 Beam, Control Device	HairMax LaserComb 2009 9 Beam n=25 Participants LLLT Device 2009 9 Beam, Control Device	Control Device n=26 Participants Control device emitting LED light	Total n=79 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	25 Participants n=7 Participants	26 Participants n=5 Participants	79 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	25 Participants n=7 Participants	26 Participants n=5 Participants	79 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline, 16 and 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	HairMax LaserComb 2009, 12 Beam n=22 hairs per cm^2 The active LLLT Device 2009 with 12 laser modules	HairMax LaserComb 2009 9 Beam n=21 hairs per cm^2 the active LLLT Device 2009 9 laser modules	Control Device n=22 hairs per cm^2 Control device emitting white light
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia Change at 16 weeks	23.5 hairs per cm^2 Standard Deviation 17.67	20.4 hairs per cm^2 Standard Deviation 14.52	4.4 hairs per cm^2 Standard Deviation 8.38
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia Change at 26 weeks	25.7 hairs per cm^2 Standard Deviation 16.92	20.9 hairs per cm^2 Standard Deviation 14.08	9.4 hairs per cm^2 Standard Deviation 12.94

Adverse Events

HairMax LaserComb 2009, 12 Beam

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

Control Device

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: 561-417-0200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place