NCT04203745

Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions

Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Skin Resurfacing and Treatment of Pigmented Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Candela Corporation · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study is intended to evaluate the efficacy and safety of a new diode fractional laser for skin resurfacing and treatment of pigmented lesions.

Detailed description

This study is a prospective, open-label, clinical trial to study the effects of the nonablative, fractional diode laser for skin resurfacing. Up to 60 eligible participants will be enrolled at up to three (3) sites. Participants will receive up to 4 treatments to the face, and other off-face locations may be treated. Participants will complete follow-up visits for clinical evaluation and photography at 1 and 3 months after the final treatment.

Conditions

• Skin Texture
• Pigmented Lesions

Interventions

Type	Name	Description
DEVICE	Nonablative Fractional Diode Laser	The FRAX 1940 is a fractional 1940 nm solid-state diode laser that delivers linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin.

Timeline

• Start date: 2019-09-18
• Primary completion: 2021-04-30
• Completion: 2021-08-05
• First posted: 2019-12-18
• Last updated: 2023-08-01
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study