NCT05460611 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
| NCT ID | NCT05460611 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Scarring Alopecia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-12-07 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2023-12-07 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and scarring alopecia.
Eligibility 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
Contact & Investigator
Kseniya Kobets, MD
PRINCIPAL INVESTIGATOR
Albert Einstein College of Medicine Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05460611 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Scarring Alopecia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05460611 currently recruiting?
Yes, NCT05460611 is actively recruiting participants. Contact the research team at ryachan@montefiore.org for enrollment information.
Where is the NCT05460611 trial being conducted?
This trial is being conducted at Elmsford, United States.
Who is sponsoring the NCT05460611 clinical trial?
NCT05460611 is sponsored by Montefiore Medical Center. The principal investigator is Kseniya Kobets, MD at Albert Einstein College of Medicine Montefiore Medical Center. The trial plans to enroll 10 participants.