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

Description

The goal of this clinical trial is to learn if the non-ablative 1470 nm laser works to treat scarring alopecia in adults. It will also learn about the biochemical pathways involved in the use of laser to treat alopecia via hair follicle gene expression analysis 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 involved in the laser treatment of 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 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 treatment

Conditions

Scarring Alopecia

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Study Overview

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Study Details

Study overview

The goal of this clinical trial is to learn if the non-ablative 1470 nm laser works to treat scarring alopecia in adults. It will also learn about the biochemical pathways involved in the use of laser to treat alopecia via hair follicle gene expression analysis 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 involved in the laser treatment of 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 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 treatment

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

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

Condition
Scarring Alopecia
Intervention / Treatment

-

Contacts and Locations

Elmsford

Montefiore Einstein Advanced Care, Elmsford, New York, United States, 10523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Healthy males and females, at least 18 years of age at time of informed consent, seeking treatment for hair loss.
  • * Subject must voluntarily sign and date an IRB approved informed consent form
  • * Subjects with diagnosis of biopsy-proven or clinically diagnosed scarring alopecia recorded over 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 as in Constantinou et al). Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months.
  • * Able to read, understand and voluntarily provide written informed consent.
  • * Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime 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 through the follow-up period.
  • * Subjects does not have the 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 for 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.
  • * History of major depressive disorders or uncontrolled endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Montefiore Medical Center,

Kseniya Kobets, MD, PRINCIPAL_INVESTIGATOR, Albert Einstein College of Medicine Montefiore Medical Center

Study Record Dates

2027-07