NCT06946550 Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
| NCT ID | NCT06946550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Scarring Alopecia |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-12-09 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5 participants in total. It began in 2025-12-09 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: 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
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.
Contact & Investigator
Kseniya Kobets, MD
PRINCIPAL INVESTIGATOR
Albert Einstein College of Medicine Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT06946550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Scarring Alopecia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06946550 currently recruiting?
Yes, NCT06946550 is actively recruiting participants. Contact the research team at ajallorina@montefiore.org for enrollment information.
Where is the NCT06946550 trial being conducted?
This trial is being conducted at Elmsford, United States.
Who is sponsoring the NCT06946550 clinical trial?
NCT06946550 is sponsored by Montefiore Medical Center. The principal investigator is Kseniya Kobets, MD at Albert Einstein College of Medicine Montefiore Medical Center. The trial plans to enroll 5 participants.