1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia

Launched by MONTEFIORE MEDICAL CENTER · Jul 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special type of laser, called a 1470 nm laser, to treat two types of hair loss: androgenetic alopecia (often known as male or female pattern baldness) and scarring alopecia (which can result in permanent hair loss due to scars on the scalp). The trial is currently looking for participants aged 18 and older who have been diagnosed with one of these conditions and have experienced hair loss in the past six months. Participants must be generally healthy and not engaged in smoking or other specific hair treatments during the study.

If you decide to join the trial, you'll receive treatment with the laser and will be asked to follow certain guidelines throughout the study. It's important to note that if you've had recent treatments for hair loss or certain medical conditions, you might not be eligible to participate. The goal of this study is to see if this laser treatment can help improve hair growth, and participants will be closely monitored to track any changes.

Gender

ALL

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
• • 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