NCT07214272

A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing

A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing Procedures Using the Next Generation Fraxel® FTX Laser System in Participants With Dyschromia, Cutaneous Lesions, and Periorbital Rhytids

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective, post-marketing (Phase 4) non-registrational single-arm, open-label, multicenter study.

Detailed description

Study to be conducted at approximately 6 investigative sites in the United States, enrolling up to 50 male and female participants with Fitzpatrick skin types I to VI, with no more 30 (60%) participants with Fitzpatrick skin types I to III and approximately 20 (40%) participants who self-identify as being of Asian descent

Conditions

• Skin Resurfacing

Interventions

Type	Name	Description
DEVICE	Fraxel® FTX Laser System	The Fraxel Laser System has two fiber-laser sources that are contained in a single Console. The Console is electrically connected to the facility power source. Laser energy produced by the unit is delivered to the tissue through the Handpiece, which is connected to the Console by the Handpiece Cable. Treatments are delivered through removable, disposable Treatment Tips which attach to the Handpiece. A Treatment Key is required to activate treatments and is inserted into the port on the side of the Touchscreen. The system includes two lasers with wavelengths of 1550 nm and 1927 nm. The two-wavelength option allows for targeted treatment of different tissue depths, and the wavelength can be selected through the Console Touchscreen. Interchangeable Tips allow for treatment of both small and large areas.

Timeline

• Start date: 2025-10-17
• Primary completion: 2026-05-01
• Completion: 2026-09-01
• First posted: 2025-10-09
• Last updated: 2026-02-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study