Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase 4 Clinical Study to Investigate the Effectiveness and Safety of Skin Resurfacing
Sponsor: Bausch Health Americas, Inc.
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
Conditions
Interventions
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