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

NCT06946550 | Recruiting DMC FDA Device

• 1 other identifier: 2025-16805
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

alopecia; laser

Outcome Measures

Primary Outcomes (4)

• Clinician Global Aesthetic Improvement Scale

  A clinician will answer the following question after evaluating baseline photos and current photos (at each specified point in time). Please choose the option that better represents the change in hair growth in the treatment area. The options will be as follows: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly worsened 2 = Moderately improved 3 = Greatly improved. Higher scores will be associated with improved hair growth in treatment area as assessed by a clinician. Group scores will be summarized by each specified point in time.

  Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15

• Subject Global Aesthetic Improvement Scale

  Subjects will answer the following questions after evaluating baseline photos and current photos (at each specified point in time). Please choose the option that better represents the change in hair growth in each treatment area from baseline to today. The options will be as follows: -3 = Greatly worsened -2 = Moderately worsened -1 = Slightly worsened 0 = No change 1 = Slightly improved 2 = Moderately improved 3 = Greatly improved, such that higher scores are associated with the subjects' self-assessment of improved aesthetic for each assessment. Group scores will be summarized by each specified point in time.

  Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15

• Hair density

  Hair density assessed using Canfield HairMetrix imaging device measured as average number of hairs (as reported by the device) per follicular unit for each treatment area (patient-dependent).

  Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15

• Hair counts

  Hair counts assessed using Canfield HairMetrix imaging device measured as average hair count per square centimeter (as reported by the device) per treatment area (patient-dependent).

  Baseline/Month 1, 2, 3, 4, 6, 9, 12, 15

Secondary Outcomes (2)

• Subject Satisfaction Questionnaire

  Month 2, Month 3, Month 4, Month 6, Month 9, Month 12, Month 15

• Change in Dermatology Life Quality Index

  From Baseline/Month 1 to Month 15

Other Outcomes (1)

• Hair follicle inflammatory and fibrosis pathway gene expression analysis

  Hair plucking to obtain hair follicle samples will be performed Month 1 (prior to the start of laser treatments) and Month 4 (1-month post completion of laser treatments)

Study Arms (1)

Scarring alopecia

EXPERIMENTAL

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.

Device: 1470nm non-ablative fractional laser

Interventions

1470nm non-ablative fractional laser DEVICE

Patients with scarring alopecia will be treated with the non-ablative Sciton HALO laser (1470nm).

Scarring alopecia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subject does not have capacity to consent to the study
• No ethnic or racial group restrictions
• Subject does not have scarring alopecia
• History of intralesional steroid injections to the scalp in the last 12 months
• Pregnant Women
• Any medical condition that in the consideration of the investigator, would present an increased risk of a photosensitivity reaction to the subject.
• Any previous hospitalization or surgical procedure in the treatment area in the past 12 months, or major surgery in the last 6 months.
• Allergy or history of prior reaction to lidocaine
• History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection), and/or any history of systemic chemotherapy in the prior 12 months.
• Recent COVID-19 infection
• History or current use of the following prescription medications:
• Immunosuppressive medications/biologics, 6 months prior to and during the study
• Accutane or other systemic retinoids within the past twelve months
• Smoking or vaping in the past 12 months.
• History of uncontrolled hyperlipidemia, uncontrolled diabetes mellitus, uncontrolled hepatitis, or uncontrolled bleeding disorders.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Sciton: collaborator
• American Society for Laser Surgery and Medicine: collaborator

Study Sites (1)

Montefiore Einstein Advanced Care

Elmsford, New York, 10523, United States

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kseniya Kobets, MD

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anika Jallorina, BS

CONTACT

618-704-8716; ajallorina@montefiore.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: April 27, 2025
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)