Study to Improve Moderate Hair Loss in People with Darker Skin Using Fractional Non-Ablative Laser Treatment

What this Trial Is About

Researchers are investigating the effects of a fractional non-ablative laser device called the FoLix laser system, which uses ErbiumGlass Fiber Laser Technology at a wavelength of 1565 nm, on hair loss improvement in healthy adults aged 21 to 55 years with moderate hair loss and Fitzpatrick skin types 5 or 6. This study aims to expand the FDA approval of this device, which is already approved for skin types 1 to 4, by assessing its safety and effectiveness for people with darker skin tones experiencing hair thinning. Participants will receive four treatments with the FoLix laser spaced four weeks apart. The study will evaluate changes in scalp hair appearance by comparing before and after images reviewed by three blinded assessors, alongside hair count measurements. The treatments involve the use of the FDA-cleared laser device targeting the scalp area affected by hair loss, and the study is designed to monitor outcomes over a 12-month period. During the study, participants will attend all scheduled visits for treatment and assessments. These include scalp examinations, digital imaging using a smart camera, and hair count assessments to track progress. Participants are also required to maintain consistent hair styling and shampoo use during the trial. Safety and improvement outcomes will be measured primarily by visual scalp hair appearance and hair count data after 12 months. The total duration of involvement for each participant is one year from the start of treatment.

Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser