A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

Study Overview
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Brief Summary
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This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks.

Detailed Description
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The purpose of this study is to evaluate the efficacy of Low Level Laser Therapy product that is configured in the novel design of a baseball cap, for promoting hair growth in females diagnosed with genetic hair loss/female pattern hair loss.

Official Title
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A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Device: Handi-Dome Laser
* Device: Incandescent red light source.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Androgenetic Alopecia / Female Pattern Hair Loss Fitzpatrick skin phototypes of I - IV Ludwig-Savin Hair Loss scale I - II In overall good health as determined by the physician investigator Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments - Exclusion Criteria: Photosensitivity to the specific wavelength of light - 650 nanometers. Malignancy in the target treatment area Other forms of alopecia of the head Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously affects the scalp. In willingness to remove hair replacement products during the 16 weeks of therapy. Using any medications deemed to inhibit hair growth as determined by the physician investigator. -

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: Incandescent red light source<br>A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. | Device: Incandescent red light source.<br>* One, 30 minute treatment, every other day for 16 weeks.<br>|
| Active Comparator: Handi-Dome Laser<br>Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. | Device: Handi-Dome Laser<br>* One, 30 minute treatment, every other day for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted. | baseline and 17 weeks | 
| Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted. | baseline and 17 weeks |