RecruitingNot ApplicableNCT05460611
1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
A Pilot Study Evaluating the Safety and Efficacy of a 1470nm Laser for the Treatment of Androgenetic Alopecia and Scarring Alopecia
Sponsor
Montefiore Medical Center
Enrollment
10 participants
Start Date
Dec 7, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria8
- 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 Criteria14
- 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
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Interventions
DEVICESciton HALO 1470nm Non-ablative laser
Patients will be treated with the 1470nm non-ablative laser.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05460611