Treatment of Androgenic Alopecia in Males

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Control Device Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 & 12 Beam Models: For the Treatment of Androgenetic Alopecia in Males

Conditions
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Androgenetic Alopecia, Hair Loss, Male Pattern Baldness

Intervention / Treatment
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* Device: HairMax LaserComb
* Device: Control device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of androgenetic alopecia Fitzpatrick Skin Types I-IV Norwood-Hamilton IIa to V Active hair loss within last 12 months Exclusion Criteria: Photosensitivity to laser light Malignancy in the target area

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HairMax LaserComb 2009, 12 Beam<br>Low Level Laser Medical Device 2009 with 12 laser beams | Device: HairMax LaserComb<br>* Device application 3 times week (non-consecutive days), for 26 weeks<br>|
| Active Comparator: HairMax LaserComb 2009 9 Beam<br>Low Level Laser Mecial Device 2009 with 9 laser beams | Device: HairMax LaserComb<br>* Device application 3 times week (non-consecutive days), for 26 weeks<br>|
| Active Comparator: Control device<br>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<br>* Device is used 3 times a week on non-consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 16 and 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgenetic Alopecia, Hair Loss, Male Pattern Baldness