RECRUITING

Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-06-01
Study Completion:2025-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05365360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 25 years and older
  2. * Men and women with AGA, untreated or with 6-month washout of previous treatments
  3. * Men: Norwood stage IIa - V
  4. * Women: Ludwig I-1 - II-2, or frontal pattern
  5. * All patients: Fitzpatrick skin types I to IV
  1. * Men: Norwood stage Va, VI, VII
  2. * Women: Ludwig stage III, advanced
  3. * All patients: Fitzpatrick skin types V, VI
  4. * Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride
  5. * Age 0-25 years

Contacts and Locations

Study Contact

Patrick Jedlowski, MD
CONTACT
(520) 694-8888
pjedlowski@email.arizona.edi

Study Locations (Sites)

Banner University Dermatology
Tucson, Arizona, 85719
United States

Collaborators and Investigators

Sponsor: University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01
Study Completion Date2025-05

Study Record Updates

Study Start Date2022-06-01
Study Completion Date2025-05

Terms related to this study

Additional Relevant MeSH Terms

  • Androgenetic Alopecia