Pathomechanisms of immune-mediated alopecia.
Alessandra Anzai, Eddy Hsi Chun Wang, Eunice Y Lee...
https://pubmed.ncbi.nlm.nih.gov/31050755/Actively Recruiting
Led by Montefiore Medical Center · Updated on 2025-12-15
5
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the use of a non-ablative 1470 nm laser to treat scarring alopecia in adults. This study aims to determine if the laser effectively treats scarring alopecia and to understand the molecular pathways affected by the laser in hair follicles. The trial includes participants with biopsy-proven or clinically diagnosed scarring alopecia who have not had recent hair loss treatments. Participants will receive three laser treatments spaced one month apart using the non-ablative Sciton HALO laser. Each session lasts about 10 to 15 minutes and involves applying a topical anesthetic and cleaning the scalp before treatment. The laser creates controlled micro-channels in the skin to minimize tissue damage while potentially improving treatment effects. After treatment, participants will follow standard care guidelines. During the study, hair follicle samples will be collected by plucking hairs before the first treatment and one month after the last treatment to analyze gene expression related to inflammation and fibrosis. Participants will attend five follow-up visits over 15 months for clinical assessments, including hair density measurement with a specialized device and photographic evaluations. They will also complete questionnaires, self-assessments, and keep a diary of any side effects. The main outcomes measured include hair density, hair counts, and aesthetic improvement scales over time.
CONDITIONS
Non-Ablative Laser to Treat Scarring Alopecia With Hair Follicle Gene Expression Analysis
A
Anika Jallorina, BS
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Montefiore Medical Center
Lead Sponsor
Sciton
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | 1470nm Non-Ablative Fractional Laser | Current Medical Care |
|---|---|---|
| What it is | A non-ablative fractional laser device (1470nm) used to deliver focused light energy to areas of scarring alopecia on the scalp. The laser is intended to stimulate local tissue response and improve hair follicle gene expression. | Standard medical therapy for scarring alopecia, including topical or intralesional corticosteroids, systemic antimalarial drugs (e.g., hydroxychloroquine), and other immunomodulatory agents (such as methotrexate or mycophenolate mofetil) to reduce scalp inflammation and suppress disease progression. |
| Role in study or clinical care | All eligible participants receive the device intervention in a single-group, open-label study to evaluate changes in scalp condition and gene expression. | Immunomodulatory drugs are prescribed as standard first-line therapies and may be used alone or in combination, based on disease severity and patient response. |
| Main intended use | To evaluate whether a non-ablative laser can improve hair density, hair counts, and scalp appearance in people with scarring alopecia who have not responded to, or plateaued with, other treatments. | To reduce scalp inflammation and slow or halt continued hair loss in scarring alopecia. |
| How it is given or performed | The laser is applied to affected scalp areas during study visits, using a protocol-defined approach with the 1470nm Sciton HALO device. The number and timing of treatments are assigned by the protocol. | Treatments are given as topical applications, scalp injections (for steroids), or oral pills, typically prescribed and monitored by a dermatologist over multiple visits. |
| Published evidence status | No published clinical outcomes for the 1470nm non-ablative laser in scarring alopecia are available yet. This trial is being conducted to establish safety and efficacy. | Current medical therapies have published evidence for reducing inflammation and slowing disease progression, but responses vary and hair regrowth is limited for many patients. |
| Important limitations | No clinical efficacy or safety results for this laser in scarring alopecia have been published yet. The device's effect on long-term disease control or hair regrowth is not established, and the study includes only a small number of participants. | Standard medical treatments often cannot reverse hair loss that has already occurred, and many patients experience only stabilization rather than regrowth. Side effects and ongoing monitoring are common, and results can vary significantly between individuals. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants receive 3 treatments with the non-ablative 1470 nm laser spaced 1 month apart to treat scarring alopecia.
3 visits (in-person), one per laser treatment
Duration - Approximately 11 months
Participants attend follow-up visits for clinical assessments including photographs, hair density evaluation, patient questionnaires, and self-assessments.
5 visits (in-person) at Month 4, Month 6, Month 9, Month 12, and Month 15
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor
Sciton
Collaborating Sponsor