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ACTIVE NOT RECRUITING
NCT07214272
NA

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

Sponsor: Bausch Health Americas, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

21 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2025-10-17

Completion Date

2026-09

Last Updated

2026-02-12

Healthy Volunteers

Yes

Interventions

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.

Locations (5)

Dermatology Cosmetic Laser Associates of La Jolla, Inc. d/b/a West Dermatology Research Center

La Jolla, California, United States

Miami Dermatology & Laser Research LLC

Miami, Florida, United States

Oak Dermatology, LLC

Naperville, Illinois, United States

Union Square Laser Dermatology, P.C

New York, New York, United States

Dermatology and Laser Surgery Center

Houston, Texas, United States