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NCT05365360 | Not yet recruiting | Androgenetic Alopecia


Sham LaserCap vs. LaserCap SD vs. LaserCap HD+
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.

Condition or disease

Androgenetic Alopecia

Intervention/treatment

LaserCap SD

Sham LaserCap

LaserCap HD+

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking : Quadruple
Primary Purpose : Treatment
Official Title : Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial
Actual Study Start Date : September 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : August 2024
Arm Intervention/treatment

Sham Comparator: Sham LaserCap

Sham device

Device: Sham LaserCap

Experimental: Lasercap SD

Low fluence LLLT

Device: LaserCap SD

Experimental: Lasercap HD+

High fluence LLLT

Device: LaserCap HD+

Ages Eligible for Study: 25 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

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Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

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