Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
NCT06946550 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2025-12-15
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
Conditions
- Scarring Alopecia
Interventions
- DEVICE
-
1470nm non-ablative fractional laser
Patients with scarring alopecia will be treated with the non-ablative Sciton HALO laser (1470nm).
Sponsors & Collaborators
-
Sciton
collaborator INDUSTRY -
American Society for Laser Surgery and Medicine
collaborator OTHER -
Montefiore Medical Center
lead OTHER
Principal Investigators
-
Kseniya Kobets, MD · Albert Einstein College of Medicine Montefiore Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-09
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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