University of Arizona
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 "photobiomodulation"3. 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.
Androgenetic Alopecia
LaserCap SD
Sham LaserCap
LaserCap HD+
Not Applicable
Study Type : | Interventional |
Estimated Enrollment : | 50 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial |
Actual Study Start Date : | September 2022 |
Estimated Primary Completion Date : | December 2023 |
Estimated Study Completion Date : | August 2024 |
Arm | Intervention/treatment |
---|---|
Sham Comparator: Sham LaserCap Sham device |
Device: Sham LaserCap |
Experimental: Lasercap SD Low fluence LLLT |
Device: LaserCap SD |
Experimental: Lasercap HD+ High fluence LLLT |
Device: LaserCap HD+ |
Ages Eligible for Study: | 25 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
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