An interventional study of HairMax LaserComb and Control device in Androgenetic Alopecia, Hair Loss and Male Pattern Baldness, sponsored by Lexington International, LLC. Completed at 3 sites in United States. Open to male participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-31.
Sponsored by Lexington International, LLC · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
This is randomized, double-blind, control device clinical study across 3 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial will involve approximately 75 male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Norwood-Hamilton IIa to V, have active hair loss within the last 12 months.
Subjects will use the device on three non-consecutive days a week as directed per device for 26 weeks treatment duration.
Safety analysis will be assessed based on the reports of adverse events during study.
609 studies on the registry are indexed under Alopecia; 131 are open to participants now.
This study's enrollment of 79 is above the median of 45 across 513 interventional studies indexed under Alopecia.
Browse Alopecia studies →Lexington International, LLC is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low Level Laser Medical Device 2009 with 12 laser beams
Device: HairMax LaserComb
Low Level Laser Mecial Device 2009 with 9 laser beams
Device: HairMax LaserComb
The control device appears identical to the active device, but utilizes 9 LED lights instead of laser lights. The randomized devices are blinded to the study investigator and distributed in a blinded manner to the participants.
Device: Control device
Device application 3 times week (non-consecutive days), for 26 weeks
Device is used 3 times a week on non-consecutive days
Changes in Terminal Hair Count at 16 and 26 Weeks Compared to Baseline in Men Diagnosed With Androgenetic Alopecia
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.
Time frame: baseline, 16 and 26 weeks
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
| Milestone | HairMax LaserComb 2009, 12 Beam | HairMax LaserComb 2009 9 Beam | Control Device |
|---|---|---|---|
| Started | 28 | 25 | 26 |
| Completed | 22 | 21 | 22 |
| Not completed | 6 | 4 | 4 |
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.
| hairs per cm^2 | HairMax LaserComb 2009, 12 Beam | HairMax LaserComb 2009 9 Beam | Control Device |
|---|---|---|---|
| Change at 16 weeks | 23.5 ± 17.67 | 20.4 ± 14.52 | 4.4 ± 8.38 |
| Change at 26 weeks | 25.7 ± 16.92 | 20.9 ± 14.08 | 9.4 ± 12.94 |
Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HairMax LaserComb 2009, 12 Beam | — | 0/28 (0%) | 0/28 (0%) |
| HairMax LaserComb 2009 9 Beam | — | 0/25 (0%) | 0/25 (0%) |
| Control Device | — | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | HairMax LaserComb 2009, 12 Beam | HairMax LaserComb 2009 9 Beam | Control Device | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 25 | 26 | 79 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | HairMax LaserComb 2009, 12 Beam | HairMax LaserComb 2009 9 Beam | Control Device | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 28 | 25 | 26 | 79 |
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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Lexington International, LLC