Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365360
• Other study ID #: LLLT Fluence RCT
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Arizona
• Contact: Patrick Jedlowski, MD
• Phone: (520) 694-8888
• Email: pjedlowski[@]email.arizona.edi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Device:
• LaserCap SD
LaserCap SD
• Sham LaserCap
Sham LaserCap
• LaserCap HD+
LaserCap HD+

Locations

Country	Name	City	State
United States	Banner University Dermatology	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Transdermal Cap, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target area total hair count at 26 weeks via phototrichogram		26 weeks
Secondary	Target area vellus hair count at 26 weeks via phototrichogram		26 weeks
Secondary	Target area terminal hair count at 26 weeks via phototrichogram		26 weeks
Secondary	Physician assessed improvement via global photography at 26 weeks		26 weeks
Secondary	Hair growth rate at 26 weeks via phototrichogram		26 weeks