Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
Launched by MONTEFIORE MEDICAL CENTER · Apr 19, 2025
Trial Information
Current as of June 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the use of a special laser treatment to help adults with scarring alopecia, a condition that causes hair loss due to scarring on the scalp. Researchers want to see if this non-ablative laser can effectively treat the condition and to understand how it works at a biological level by analyzing changes in hair follicles before and after treatment. Participants will receive three laser treatments over three months and will attend follow-up visits to track their progress. They will also provide hair samples for analysis and fill out questionnaires about their experience.
To be eligible for the study, participants must be at least 18 years old and have a confirmed diagnosis of scarring alopecia. They should be in good health and not have had certain treatments or conditions that could interfere with the study. Throughout the trial, participants will need to keep a diary of any side effects and follow the treatment schedule without making changes to their hair care routine. This trial is not yet recruiting participants, but it aims to gather important information that could help improve treatments for scarring alopecia in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
- • History of major depressive disorders or uncontrolled endocrine disorders including but not limited to; hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism.
About Montefiore Medical Center
Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Elmsford, New York, United States
Patients applied
Trial Officials
Kseniya Kobets, MD
Principal Investigator
Albert Einstein College of Medicine Montefiore Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported