NCT06885112

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6

Detailed 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.

Conditions

• Hair Loss

Interventions

Type	Name	Description
DEVICE	FoLix 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

Timeline

• Start date: 2025-02-21
• Primary completion: 2027-02-21
• Completion: 2027-02-21
• First posted: 2025-03-20
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study