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

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.

Study Overview

• Status: Recruiting
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Device: Sham LaserCap; Device: LaserCap SD; Device: LaserCap HD+

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Jedlowski, MD; Phone Number: (520) 694-8888; Email: pjedlowski@email.arizona.edi

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Recruiting
      • Banner University Dermatology
      • Contact: Patrick M Jedlowski, MD; Phone Number: 520-621-7168
      • Sub-Investigator: Patrick M Jedlowski, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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+

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target area total hair count at 26 weeks via phototrichogram	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Target area vellus hair count at 26 weeks via phototrichogram	26 weeks
Target area terminal hair count at 26 weeks via phototrichogram	26 weeks
Physician assessed improvement via global photography at 26 weeks	26 weeks
Hair growth rate at 26 weeks via phototrichogram	26 weeks

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: Transdermal Cap, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: LLLT Fluence RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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