Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser
Lumenis Be Ltd.
Summary
The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6
Description
The FoLix laser system contains Erbium:Glass Fiber Laser Technology with a wavelength of 1565 nm. It is the first FDA cleared fractional laser device for treatment of hair loss that has demonstrated safety and efficacy.
Eligibility
- Age range
- 21–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Male and females between 21 - 55 years of age, inclusive. * Have Fitzpatrick Skin Type V to VI. * Have mild to moderate hair loss (Ludwig scale I-II for women, Norwood-Hamilton scale I-III for males) * Have self-reported thinning or hair loss for more than 6 months prior to screening but less than 5 years. * Clinically confirmed to have hair loss or thinning by the investigator via physical exam * Didn't receive hair-loss treatments or participated in a clinical study using 1565 NAFL device * In good general health, as determined by the Investigator * Willing and able to…
Interventions
- DeviceFoLix treatment for improving the scalp hair appearance
The study patients will receive 4 FoLix treatment in 4 weeks intervals. the scalp hair improvement will be evaluated by 3 blinded assessors who shall review before and after images, as well as hair count data
Location
- UnionDermNew York, New York