1470 nm Non-Ablative Laser for the Treatment of Scarring Alopecia: A Clinical and Mechanistic Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults. The study will also investigate the biochemical molecular pathways involved in laser therapy by analyzing hair follicle gene expression before and after laser treatment. The main questions it aims to answer are: 1. Does a non-ablative laser work to effectively treat scarring alopecia? 2. What molecular pathways are associated with the laser's effects on hair follicles in scarring alopecia? Participants with scarring alopecia will: * Receive 3 laser treatments, spaced 1 month apart (Month 1, Month 2, Month 3), and attend 5 follow-up visits (Month 4, Month 6, Month 9, Month 12 and Month 15) * Have hair follicle samples collected via hair plucking of 10 hairs prior to the start and 1-month post-completion of laser treatments for gene expression analysis of inflammatory and fibrosis pathways implicated in scarring alopecia. Hair samples will be de-identified and kept anonymous. * Fill out questionnaires at each visit * Keep a diary of any side effects from laser treatments

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for scarring alopecia

• Subject must be able to read, understand, and voluntarily sign and date an IRB-approved informed consent form

• Subjects with biopsy-proven or clinically diagnosed scarring alopecia recorded within the past 6 months. An established clinical diagnosis will be confirmed by a licensed dermatologist as in previously published hair plucking studies (eg. using trichoscopy and a positive pull test). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.

• Subject agrees to not make any changes to their daily hair treatment regimen or start any medications for hair loss such as minoxidil during the study.

• Subjects able and willing to comply with the treatment protocol and follow-up schedule and requirements.

• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated throughout the follow-up period.

Locations
United States
New York
Montefiore Einstein Advanced Care
RECRUITING
Elmsford
Contact Information
Primary
Anika Jallorina, BS
ajallorina@montefiore.org
618-704-8716
Time Frame
Start Date: 2025-10
Estimated Completion Date: 2027-10
Participants
Target number of participants: 5
Treatments
Experimental: Scarring alopecia
Patients with scarring alopecia will receive 3 treatments with the non-ablative Sciton HALO laser (1470nm). Each laser treatment will take approximately 10 to 15 minutes per subject.
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center
Collaborators: Sciton, American Society for Laser Surgery and Medicine

This content was sourced from clinicaltrials.gov