Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

University of Arizona

Status: Enrolling

Conditions: Androgenetic Alopecia

Treatments: Device: LaserCap HD+; Device: Sham LaserCap; Device: LaserCap SD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05365360

LLLT Fluence RCT

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Men: Norwood stage Va, VI, VII
• Women: Ludwig stage III, advanced
• All patients: Fitzpatrick skin types V, VI
• Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride
• Age 0-25 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

50 participants in 3 patient groups

Sham LaserCap

Sham Comparator group

Description:

Sham device

Treatment:

Device: Sham LaserCap

Lasercap SD

Experimental group

Description:

Low fluence LLLT

Treatment:

Device: LaserCap SD

Lasercap HD+

Experimental group

Description:

High fluence LLLT

Treatment:

Device: LaserCap HD+