Treatment of Androgenetic Alopecia in Females, 12 Beam

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 12 beam model for androgenetic alopecia in females when treatment is applied as directed.

Detailed Description
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This is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair). The trial with 63 female 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 Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months. Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks 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 Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females

Conditions
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Androgenetic Alopecia, Hair Loss, Female Pattern Baldness

Intervention / Treatment
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* Device: HairMax LaserComb 2009 model 12 beam
* Device: Sham Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of androgenetic alopecia Fitzpatrick Skin types I-IV Ludwig I-4, II-1, II-2, or frontal Active hair loss within last 12 months Exclusion Criteria: Photosensitivity to laser light Malignancy in the target area Pregnancy Lactating females

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

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Sham Comparator: Sham Device<br>Sham device | Device: Sham Device<br>* Sham Device<br>|
| Active Comparator: LLT Device 2009 12 Beams<br>HairMax LaserComb 2009 model 12 beam | Device: HairMax LaserComb 2009 model 12 beam<br>* HairMax LaserComb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hair Count at 16 and 26 Weeks Over Baseline | 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 weeks, 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, Female Pattern Baldness