Status:
RECRUITING
Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Sciton
American Society for Laser Surgery and Medicine
Conditions:
Scarring Alopecia
Eligibility:
All Genders
18+ years
Phase:
NA
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 path...
Detailed Description
This is a prospective, single-center, open-label, baseline-controlled study evaluating the molecular pathways of the effects of a non-ablative 1470 nm laser for the treatment of scarring alopecia. 5 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06946550
Start Date
December 9 2025
End Date
December 1 2027
Last Update
December 15 2025
Active Locations (1)
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1
Montefiore Einstein Advanced Care
Elmsford, New York, United States, 10523