NCT04953416

Fractional Non-ablative Laser for the Treatment of Hair Loss

Evaluation of Safety and Performance of Fractional Non-ablative Laser for the Treatment of Hair Loss - A Pilot Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Lumenis Be Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single center, prospective, open label clinical trial with before-after study design. The study is designed to evaluate the feasibility of hair growth in female and male pattern hair loss (androgenic alopecia, telogen effluvium, and alopecia areata) using a fractional non-ablative 1565nm ResurFX module.

Detailed description

This is a single center, prospective, open label clinical trial with before-after study design. The study is designed to evaluate the feasibility of hair growth in female and male pattern hair loss (androgenic alopecia, alopecia areata) using a fractional non-ablative 1565nm ResurFX module. This study will include up to 13 visits at the clinic: screening; at least 5 and up to 10 treatment (Tx) visits 14+/-3 days apart, and follow up (FU) visits at 1 and 3 months (each can be +/-7 days out of window) after the last treatment session. See Figure 3: Study Design for an illustration of the study design, for a summary of the study procedures and Table 1 for the schedule of times and events. The study population will include up to 35 healthy subjects.

Conditions

• Alopecia

Interventions

Type	Name	Description
DEVICE	1565nm non ablative fractional laser	The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber.

Timeline

• Start date: 2020-09-08
• Primary completion: 2022-01-01
• Completion: 2022-03-01
• First posted: 2021-07-08
• Last updated: 2021-07-08

Locations

1 site across 1 country: Ukraine