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

NCT07214272 | Active Not Recruiting FDA Device

• 1 other identifier: FX-PAS-USA-2024-001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Skin Resurfacing

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Proportion of participants with any improvement after 3 treatments as assessed by Investigator Global Aesthetic Improvement Scale (iGAIS) at End of Study

  26 weeks

Secondary Outcomes (1)

• Secondary Endpoint

  26 weeks

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Device: Fraxel® FTX Laser System

Interventions

Fraxel® FTX Laser System DEVICE

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.

Treatment Arm

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female.
• to 60 years of age.
• Written informed consent must be obtained prior to any study procedures.
• Presence of one or more of the following in the treatment area(s):
• Photodamage as determined by investigator using a Modified Griffith's Scale (score of 3 to 7 in overall photodamage on the 9-point scale)
• Mild-to-moderate rhytids (e.g., periorbital crow's feet) as determined by investigator using a Modified Griffith's Scale (score of 3 to 6 on the 9-point scale).
• Mild-to-severe dyschromia, including lentigos or solar lentigines as determined by investigator using the Modified Griffith's Scale (score of 3 to 9 on the 9-point scale).
• Ability to read, understand, and sign the informed consent form

You may not qualify if:

• Pregnant, breastfeeding, or planning to become pregnant during the study.
• History of any type of allergic reaction to topical anesthetics.
• Localized infection in the treatment area or systemic infection within the last 1 month prior to or at any time during the study.
• Presence of melasma, rosacea, significant actinic keratoses, or other significant skin conditions in the target treatment zone.
• Presence of skin cancer, infection, cold sore, open wounds, burns, psoriasis, or active dermatitis of any kind (atopic, contact, significant seborrheic dermatitis) in the target treatment zone.
• Presence of skin conditions that, in the judgement of the investigator, would increase the risk of study participation or treatment.
• Predisposition to keloid formation or excessive scarring.
• Diagnosis of a condition that may compromise the immune system, such as: HIV, lupus, and/or scleroderma.
• Known sensitivity to light or photosensitizing agents/medications are being taken that the investigator determines may affect study treatment.
• Use of systemic steroids (e.g. prednisone, dexamethasone) or other immunosuppressants within 1 month prior to enrollment to or at any time during the study.
• Use of topical retinoids within 2 weeks prior to enrollment or at any time during the study.
• Use of systemic retinoids within 6 months prior to enrollment or at any time during the study.
• Had a cosmetic procedure, such as a chemical peel, mechanical peel, laser resurfacing, and/or skin tightening procedures (microneedling, ultrasound, etc.) within the previous 4 months prior to enrollment.
• Receiving short-acting botulinum toxin within 4 months or long-acting botulinum toxin administered to the targeted treatment zone within 9 months prior to enrollment or at any time during the study.
• Receiving dermal fillers administered to the targeted treatment zone within 3 months prior to enrollment or at any time during the study.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (5)

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

La Jolla, California, 92121, United States

Location

Miami Dermatology & Laser Research LLC

Miami, Florida, 33133, United States

Location

Oak Dermatology, LLC

Naperville, Illinois, 60563, United States

Location

Union Square Laser Dermatology, P.C

New York, New York, 10003, United States

Location

Dermatology and Laser Surgery Center

Houston, Texas, 77004, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 9, 2025
• Study Start: October 17, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)