Non-ablative 1470 nm laser treatment for scarring alopecia with hair follicle gene analysis
1470 nm Non-Ablative Laser for the Treatment of Scarring Alopecia: A Clinical and Mechanistic Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Elmsford, New York) |
| Trial ID | NCT06946550 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Elmsford, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.