Using a 1470nm laser to treat hair loss conditions
Official title: A Pilot Study Evaluating the Safety and Efficacy of a 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Run by Montefiore Medical Center · NCT05460611 · Data updated 2026-11-12
This study is testing whether a special 1470 nm laser can help people with certain types of hair loss grow more hair.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Elmsford, New York) |
| Status | Recruiting |
| Started | December 7, 2023 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT05460611 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults aged 18 and older with biopsy-proven androgenetic or scarring alopecia.
✕Probably not a fit
Patients who are smokers or those unable to comply with the treatment protocol may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is relatively novel, similar laser treatments have shown promise in other studies for hair restoration.
Who can join: the full rules
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 * 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 it's running
-
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: Ryan Chan, BA
- Email: ryachan@montefiore.org
- Phone: 631-553-2203
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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PP405 0.05% topically applied gel for adult men with pattern hair loss
A topical gel called PP405 is being tested in adult men with androgenetic alopecia to see if it can help with hair growth and is safe over a year.
-
EPI-001 for androgenetic alopecia in adults
This early-phase study tests autologous dermal papilla cell therapy (EPI-001) to see if it is safe and can help hair grow in people with androgenetic alopecia.
-
JAK2 levels in balding and non-balding scalp before and after topical minoxidil
This will test whether three months of topical minoxidil changes JAK2 protein levels in the scalps of adults (18–50) with mild to moderate androgenetic alopecia.
-
Secretome versus PRP injections to improve hair density in androgenetic alopecia
This will try secretome injections versus platelet-rich plasma (PRP) injections to see which more effectively increases hair density and the terminal-to-vellus hair ratio in adults with androgenetic alopecia.
-
Fractional laser plus exosome vs. laser plus placebo for androgenetic alopecia
This study tests whether adding a human umbilical cord mesenchymal stem cell exosome solution to fractional laser therapy helps men with androgenetic alopecia grow more hair than laser therapy with a placebo.
-
Once-daily 5% minoxidil foam for female pattern hair loss
This will try once-daily 5% minoxidil foam to see if it increases hair count in adult women with androgenetic alopecia compared with a placebo.
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.