Non-ablative 1470 nm laser treatment for scarring alopecia with hair follicle gene analysis
Official title: 1470 nm Non-Ablative Laser for the Treatment of Scarring Alopecia: A Clinical and Mechanistic Study
Run by Montefiore Medical Center · NCT06946550 · Data updated 2026-11-12
This study will test whether a non-ablative 1470 nm laser can help adults with scarring alopecia and will check hair follicle gene changes before and after treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Elmsford, New York) |
| Status | Recruiting |
| Started | December 9, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | December 15, 2025 |
| Trial ID | NCT06946550 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with biopsy-proven or clinically diagnosed scarring alopecia who are treatment-naive or at least one year since prior hair-loss medical therapy and able to attend in-person visits are ideal candidates.
✕Probably not a fit
Patients with non-scarring forms of hair loss, unstable hair treatment regimens, recent hair-loss therapies, or who cannot attend the required visits are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center, open-label baseline-controlled study will enroll five adults with biopsy-proven or clinically diagnosed scarring alopecia. Each participant will receive three non-ablative 1470 nm fractional laser treatments one month apart (Months 1–3) and attend follow-up visits at Months 4, 6, 9, 12, and 15. Investigators will collect hair follicle samples by plucking ten hairs before the first treatment and one month after the final treatment to analyze gene expression related to inflammation and fibrosis. Treatment uses the Sciton HALO 1470 nm device to create dermal microchannels with minimal downtime, and outcomes will be compared to each participant’s baseline.
Why it matters
Potential benefit: If successful, the treatment could reduce scarring-related hair loss and identify molecular pathways to guide more targeted therapies.
How similar studies have gone: Non-ablative and fractional lasers have shown promise in small case series for scarring alopecia and for improving skin fibrosis, but controlled data and paired hair follicle gene expression analyses are limited, making this approach largely exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Montefiore Einstein Advanced Care
Elmsford, New York, United States Recruiting
Study contacts
- Principal investigator: Kseniya Kobets, MD — Albert Einstein College of Medicine Montefiore Medical Center
- Study coordinator: Anika Jallorina, BS
- Email: ajallorina@montefiore.org
- Phone: 618-704-8716
Similar studies
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Using a 1470nm laser to treat hair loss conditions
This study is testing whether a special 1470 nm laser can help people with certain types of hair loss grow more hair.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.