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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Healthy Volunteers: t
View:

• 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

Locations
United States
Arizona
Banner University Dermatology
RECRUITING
Tucson
Contact Information
Primary
Patrick Jedlowski, MD
pjedlowski@email.arizona.edi
(520) 694-8888
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2025-05
Participants
Target number of participants: 50
Treatments
Sham_comparator: Sham LaserCap
Sham device
Experimental: Lasercap SD
Low fluence LLLT
Experimental: Lasercap HD+
High fluence LLLT
Related Therapeutic Areas
Sponsors
Collaborators: Transdermal Cap, Inc.
Leads: University of Arizona

This content was sourced from clinicaltrials.gov