Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

Not Applicable

Recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Device: Sham LaserCap; Device: LaserCap HD+; Device: LaserCap SD

• Registration Number: NCT05365360
• Lead Sponsor: University of Arizona

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 "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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-12
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham LaserCap	Sham LaserCap	Sham device
Lasercap HD+	LaserCap HD+	High fluence LLLT
Lasercap SD	LaserCap SD	Low fluence LLLT

Primary Outcome Measures

Name	Time	Method
Target area total hair count at 26 weeks via phototrichogram	26 weeks

Secondary Outcome Measures

Name	Time	Method
Hair growth rate 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
Target area vellus hair count at 26 weeks via phototrichogram	26 weeks

Trial Locations

Locations (1)

Banner University Dermatology; 🇺🇸 Tucson, Arizona, United States