Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06946550

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

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

5

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Montefiore Medical Center

Lead Sponsor

S

Sciton

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a non-ablative 1470 nm laser to treat scarring alopecia in adults. This study aims to determine if the laser effectively treats scarring alopecia and to understand the molecular pathways affected by the laser in hair follicles. The trial includes participants with biopsy-proven or clinically diagnosed scarring alopecia who have not had recent hair loss treatments. Participants will receive three laser treatments spaced one month apart using the non-ablative Sciton HALO laser. Each session lasts about 10 to 15 minutes and involves applying a topical anesthetic and cleaning the scalp before treatment. The laser creates controlled micro-channels in the skin to minimize tissue damage while potentially improving treatment effects. After treatment, participants will follow standard care guidelines. During the study, hair follicle samples will be collected by plucking hairs before the first treatment and one month after the last treatment to analyze gene expression related to inflammation and fibrosis. Participants will attend five follow-up visits over 15 months for clinical assessments, including hair density measurement with a specialized device and photographic evaluations. They will also complete questionnaires, self-assessments, and keep a diary of any side effects. The main outcomes measured include hair density, hair counts, and aesthetic improvement scales over time.

CONDITIONS

Brief 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 of age at time of informed consent, seeking treatment for scarring alopecia
  • Able to read, understand, and voluntarily sign an IRB-approved informed consent form
  • Biopsy-proven or clinically diagnosed scarring alopecia within the past 6 months confirmed by a dermatologist
  • Stable hair loss treatment regimen with plateau in results for at least 3 months
  • Agree not to change daily hair treatment or start new hair loss medications during the study
  • Willing and able to comply with treatment protocol and follow-up schedule
  • Agree not to undergo other procedures in treated areas during follow-up period
Not Eligible

You will not qualify if you...

  • Unable to consent to the study
  • No scarring alopecia diagnosis
  • Received intralesional steroid injections to the scalp within the last 12 months
  • Pregnant women
  • Medical conditions increasing risk of photosensitivity reaction
  • Hospitalization or surgery in treatment area within past 12 months or major surgery within past 6 months
  • Allergy or prior reaction to lidocaine
  • Immunosuppression or immune deficiency disorders, including AIDS or HIV
  • Systemic chemotherapy within prior 12 months
  • Recent COVID-19 infection
  • Use of immunosuppressive medications or biologics within 6 months prior to and during study
  • Taken Accutane or other systemic retinoids within past 12 months
  • Smoking or vaping in past 12 months
  • History of uncontrolled hyperlipidemia, diabetes, hepatitis, or bleeding disorders
  • History of major depressive disorders or uncontrolled endocrine disorders including hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3 months

Participants receive 3 treatments with the non-ablative 1470 nm laser spaced 1 month apart to treat scarring alopecia.

3 visits (in-person), one per laser treatment

Follow-up

Duration - Approximately 11 months

Participants attend follow-up visits for clinical assessments including photographs, hair density evaluation, patient questionnaires, and self-assessments.

5 visits (in-person) at Month 4, Month 6, Month 9, Month 12, and Month 15

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

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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Taylor A Jamerson, C Conover Talbot, Yemisi Dina...

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Sung Bin Cho, Boncheol Leo Goo, Zhenlong Zheng...

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Erbium: YAG laser (2,940 nm) treatment stimulates hair growth through upregulating Wnt 10b and β-catenin expression in C57BL/6 mice.

Jin Ke, Huiwen Guan, Shan Li...

https://pubmed.ncbi.nlm.nih.gov/26885014

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