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Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

Sponsor
University of Arizona (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05365360
Collaborator
Transdermal Cap, Inc. (Industry)
50
Enrollment
3
Arms
23
Anticipated Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase
  • Device: LaserCap SD
  • Device: Sham LaserCap
  • Device: LaserCap HD+
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Increasing Fluence on Efficacy of Low Level Laser Therapy for Androgenetic Alopecia, a Randomized Control Trial
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Sham LaserCap

Sham device

Device: Sham LaserCap
Sham LaserCap
Experimental: Lasercap SD

Low fluence LLLT

Device: LaserCap SD
LaserCap SD
Experimental: Lasercap HD+

High fluence LLLT

Device: LaserCap HD+
LaserCap HD+

Outcome Measures

Primary Outcome Measures

  1. Target area total hair count at 26 weeks via phototrichogram [26 weeks]

Secondary Outcome Measures

  1. Target area vellus hair count at 26 weeks via phototrichogram [26 weeks]

  2. Target area terminal hair count at 26 weeks via phototrichogram [26 weeks]

  3. Physician assessed improvement via global photography at 26 weeks [26 weeks]

  4. Hair growth rate at 26 weeks via phototrichogram [26 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Arizona
  • Transdermal Cap, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Arizona
ClinicalTrials.gov Identifier:
NCT05365360
Other Study ID Numbers:
  • LLLT Fluence RCT
First Posted:
May 9, 2022
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Alopecia
Alopecia Areata

Study Results

No Results Posted as of May 9, 2022