Recruiting

LaserCap SD vs. LaserCap HD+

Sponsor:

University of Arizona

Code:

NCT05365360

Conditions

Androgenetic Alopecia

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Accepted

Interventions

LaserCap SD

Sham LaserCap

LaserCap HD+

Study Details

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.

Conditions

Androgenetic Alopecia

Study ID

NCT05365360

Start date

Jun 1, 2022

Status verified date

May, 2024

Completion date

May, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham LaserCap

Sham device

experimental: Lasercap SD

Low fluence LLLT

experimental: Lasercap HD+

High fluence LLLT

Interventions

LaserCap SD

LaserCap SD

Sham LaserCap

Sham LaserCap

LaserCap HD+

LaserCap HD+

Primary outcome measure

  • Target area total hair count at 26 weeks via phototrichogram [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Locations

Banner University Dermatology

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Patrick M Jedlowski, MD

520-621-7168

More Information

Sponsor

University of Arizona

Last update posted

May 7, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2024-05-07.