Treatment of Androgenetic Alopecia in Males

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 7 Beam model in promoting hair growth in males diagnosed with androgenetic alopecia when treatment is applied as directed.

Detailed Description
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This is randomized, double-blind, control device clinical study across 2 sites, evaluating changes in terminal hair-count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). The trial will involve 45 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 nonconcurring days a week as directed per device for 26 weeks treatment duration. Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16). 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, 7 Beam Model: 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 2009, 7 Beam
* Device: HairMax LaserComb


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, 7 Beam<br>Lower level laser phototherapy medical device with 7 laser beams | Device: HairMax LaserComb 2009, 7 Beam<br>* Device application 3 times week (non-consecutive days), for 26 weeks<br>* Other names: HairMax LaserComb;|
| Active Comparator: Control Device<br>Identical to the Active device, but with 7 LED's instead of lasers | Device: HairMax LaserComb<br>* Device application 3 times week (non-consecutive days), for 26 weeks<br>* Other names: Control device;|

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 Over Baseline | Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region | 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