NCT05365360

Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Androgenetic Alopecia

Interventions

Type	Name	Description
DEVICE	LaserCap SD	LaserCap SD
DEVICE	Sham LaserCap	Sham LaserCap
DEVICE	LaserCap HD+	LaserCap HD+

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-12-01
• Completion: 2025-05-01
• First posted: 2022-05-09
• Last updated: 2024-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study