Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06946550

Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis

Led by Montefiore Medical Center · Updated on 2025-12-15

5

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

S

Sciton

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males and females at least 18 years old seeking treatment for scarring alopecia
  • Able to read, understand, and voluntarily sign an informed consent form
  • Biopsy-proven or clinically diagnosed scarring alopecia within the past 6 months confirmed by a licensed dermatologist
  • Stable hair loss treatment regimen with no changes for at least 3 months
  • Agree not to change hair treatment or start new hair loss medications during the study
  • Willing and able to follow the treatment and follow-up schedule
  • Agree not to have other procedures in the treated areas during the follow-up period
Not Eligible

You will not qualify if you...

  • Unable to consent to the study
  • Do not have scarring alopecia
  • History of steroid injections to the scalp in the past 12 months
  • Pregnant women
  • Medical conditions increasing risk of photosensitivity
  • Hospitalization or surgery in the treatment area within the past 12 months, or major surgery in the last 6 months
  • Allergy or prior reaction to lidocaine
  • History of immunosuppression or immune deficiency disorders, including HIV/AIDS
  • History of systemic chemotherapy within 12 months
  • Recent COVID-19 infection
  • Use of immunosuppressive medications or biologics within 6 months prior to or during the study
  • Use of Accutane or systemic retinoids within 12 months
  • Smoking or vaping within the past 12 months
  • History of uncontrolled hyperlipidemia, diabetes, hepatitis, or bleeding disorders
  • History of major depressive or uncontrolled endocrine disorders including hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism

AI-Screening

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Trial Site Locations

Total: 1 location

1

Montefiore Einstein Advanced Care

Elmsford, New York, United States, 10523

Actively Recruiting

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Research Team

A

Anika Jallorina, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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