Using a 1470nm laser to treat hair loss conditions
A Pilot Study Evaluating the Safety and Efficacy of a 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
This study is testing whether a special 1470 nm laser can help people with certain types of hair loss grow more hair.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Elmsford, New York) |
| Trial ID | NCT05460611 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of a non-ablative 1470 nm laser in treating androgenetic alopecia and scarring alopecia. Conducted at a single center, it will enroll up to 10 participants with biopsy-proven alopecia, divided into two treatment arms. Each participant will receive up to three laser treatments, with follow-up visits scheduled at 6, 9, 12, and 15 months to assess hair density and treatment outcomes. The laser treatment aims to create micro-channels in the scalp to enhance hair regrowth while minimizing tissue damage.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 and older with biopsy-proven androgenetic or scarring alopecia.
Not a fit: Patients who are smokers or those unable to comply with the treatment protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive option for patients suffering from hair loss.
How similar studies have performed: While this approach is relatively novel, similar laser treatments have shown promise in other studies for hair restoration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy males and females, ≥ 18 years of age at time of informed consent, seeking treatment for hair loss * Subject must voluntarily sign and date an IRB approved informed consent form * Subjects with diagnosis of biopsy proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months * Subjects must have a stable hair loss treatment regimen with a plateau in results for at least 3 months * Able to read, understand and voluntarily provide written informed consent * Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regimen 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 through the follow-up period Exclusion Criteria: * Subject does not have the capacity to consent to the study * Subject has other types of alopecia of the scalp like alopecia areata * Use of minoxidil or 5-alpha reductase inhibitors (i.e., finasteride, dutasteride) 3 months prior to screening date * 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 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 for prior 12 months * History or current use of the following prescription medications: i. Immunosuppressive medications/biologics, 6 months prior to and during the study ii. Accutane or other systemic retinoids within the past twelve months * Smoking or vaping in the past 12 months * History of uncontrolled hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders * History of major depressive disorders or 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.