Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

NCT05365360 | Recruiting FDA Device

• 1 other identifier: LLLT Fluence RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Target area total hair count at 26 weeks via phototrichogram

  26 weeks

Secondary Outcomes (4)

• 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

Study Arms (3)

Sham LaserCap

SHAM COMPARATOR

Sham device

Device: Sham LaserCap

Lasercap SD

EXPERIMENTAL

Low fluence LLLT

Device: LaserCap SD

Lasercap HD+

EXPERIMENTAL

High fluence LLLT

Device: LaserCap HD+

Interventions

LaserCap SD DEVICE

LaserCap SD

Lasercap SD

Sham LaserCap DEVICE

Sham LaserCap

Sham LaserCap

LaserCap HD+ DEVICE

LaserCap HD+

Lasercap HD+

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• Transdermal Cap, Inc.: collaborator

Study Sites (1)

Banner University Dermatology

Tucson, Arizona, 85719, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patrick Jedlowski, MD

CONTACT

(520) 694-8888; pjedlowski@email.arizona.edi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)