RecruitingNot ApplicableNCT05365360

Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

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


Sponsor

University of Arizona

Enrollment

50 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

DEVICELaserCap SD

LaserCap SD

DEVICESham LaserCap

Sham LaserCap

DEVICELaserCap HD+

LaserCap HD+


Locations(1)

Banner University Dermatology

Tucson, Arizona, United States

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NCT05365360


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