Actively Recruiting
A Pilot Study Evaluating the Safety and Efficacy of a 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Led by Montefiore Medical Center · Updated on 2025-05-22
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
S
Sciton
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a non-ablative 1470 nm laser to treat androgenetic alopecia and scarring alopecia in adults. This pilot study is open-label, baseline-controlled, and conducted at a single center. The study includes participants with biopsy-proven alopecia who have experienced stable hair loss for at least six months. The goal is to explore the laser's effects on hair loss improvement, as it has not yet been tested for these conditions despite FDA clearance for dermatologic use. Participants will be divided into two groups, each with five people: one group for androgenetic alopecia and one for scarring alopecia. Each subject may receive up to three laser treatments targeting multiple areas of the scalp. Treatments last about 10 to 15 minutes and follow a protocol that includes topical anesthetic and antiseptic cleaning before the laser application. Post-treatment care includes applying a topical steroid cream. Follow-up visits are scheduled at months 6, 9, 12, and 15 to monitor progress. Throughout the study, researchers will conduct clinical assessments including standardized photography and hair density measurements using the Canfield HairMetrix® device. Participants will complete questionnaires to report pain levels, hair growth self-assessments, and any adverse events. Primary outcomes include live and photographic assessments of hair loss, hair density, and hair counts at multiple timepoints up to month 15. Subject satisfaction will also be tracked. The study duration allows careful monitoring of changes and safety over more than a year.
CONDITIONS
Brief Title
1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 18 years or older at time of informed consent
- Diagnosis of biopsy-proven androgenetic alopecia or scarring alopecia with hair loss recorded over the past 6 months
- Stable hair loss treatment regimen with plateaued results for at least 3 months
- Able to read, understand, and voluntarily sign an informed consent form
- Healthy non-smoker agreeing not to change daily hair treatment during the study
- Willing and able to comply with treatment protocol and follow-up schedule
- Understands and agrees not to undergo other procedures in treated areas during follow-up
You will not qualify if you...
- Lacking capacity to consent to the study
- Having other types of alopecia such as alopecia areata
- Use of minoxidil or 5-alpha reductase inhibitors within 3 months prior to screening
- History of intralesional steroid injections to the scalp in the last 12 months
- Pregnant women
- Medical conditions increasing risk of photosensitivity
- Surgical procedures in treatment area within past 12 months or major surgery in past 6 months
- Allergy or prior reaction to lidocaine
- History of immunosuppression, immune deficiency, or systemic chemotherapy within past 12 months
- Use of immunosuppressive medications or biologics within 6 months prior and during study
- Use of Accutane or systemic retinoids within past 12 months
- Smoking or vaping within past 12 months
- History of uncontrolled hyperlipidemia, diabetes mellitus, hepatitis, or bleeding disorders
- History of major depressive or endocrine disorders including hypothyroidism, Hashimoto's thyroiditis, or hyperthyroidism
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Up to 3 treatment sessions over several weeks
Participants receive up to three treatments using the 1470nm non-ablative laser on affected scalp areas to improve hair loss.
Up to 3 treatment visits (in-person)
Duration - 15 months
Participants attend follow-up visits for clinical assessments including photographs and hair density measurements to evaluate treatment effects.
Follow-up visits at months 6, 9, 12, and 15 (in-person)
Trial Site Locations
Total: 1 location
1
Montefiore Einstein Advanced Care
Elmsford, New York, United States, 10523
Actively Recruiting
Research Team
A
Anika Jallorina, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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