Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

Study Overview
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Brief Summary
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Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1. In addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the  650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed photobiomodulation3. Recent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.

Official Title
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Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Device: LaserCap SD
* Device: Sham LaserCap
* Device: LaserCap HD+


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 25 years and older Men and women with AGA, untreated or with 6-month washout of previous treatments Men: Norwood stage IIa - V Women: Ludwig I-1 - II-2, or frontal pattern All patients: Fitzpatrick skin types I to IV Exclusion criteria: Men: Norwood stage Va, VI, VII Women: Ludwig stage III, advanced All patients: Fitzpatrick skin types V, VI Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride Age 0-25 years

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

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 LaserCap<br>Sham device | Device: Sham LaserCap<br>* Sham LaserCap<br>|
| Experimental: Lasercap SD<br>Low fluence LLLT | Device: LaserCap SD<br>* LaserCap SD<br>|
| Experimental: Lasercap HD+<br>High fluence LLLT | Device: LaserCap HD+<br>* LaserCap HD+<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target area total hair count at 26 weeks via phototrichogram |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target area vellus hair count at 26 weeks via phototrichogram |  | 26 weeks | 
| Target area terminal hair count at 26 weeks via phototrichogram |  | 26 weeks | 
| Physician assessed improvement via global photography at 26 weeks |  | 26 weeks | 
| Hair growth rate at 26 weeks via phototrichogram |  | 26 weeks |