Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05365360
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2022-05-04
Brief Title:
Sham LaserCap vs LaserCap SD vs LaserCap HD
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia a Randomized Control Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 115 Jcm2 low fluence and LaserCap HD 393 Jcm2 high fluence in RCT
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 115 Jcm2 low fluence and LaserCap HD 393 Jcm2 high fluence in RCT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None