Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles

NCT ID: NCT03715049

Last Updated: 2018-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2017-12-31

Brief Summary

Objective 1: To evaluate the effect and histologic (cellular) changes associated with varying energy and density settings of the Fraxel Repair Laser to determine an optimal dose response.

Objective 2: To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.

Detailed Description

To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.

This is a multi-site, non-randomized, non-controlled investigator initiated study designed to follow a total of 30 qualified and consenting subjects treated with one Fraxel Repair treatment in the course of clinical practice.

Conditions

Wrinkle

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fraxel Laser Treatment

Using the energy and density settings within the FDA approved limits (5-40mJ at 30-100% density) that were narrowed down by the pre-clinical portion of the study, and analysis of abdominal and facial tissue treated in Objective 1, up to thirty (30) subjects will be recruited and treated one (1) time in the perioral region of the upper lip and followed for 6 months (study design below). The acute effects of the laser application will be determined by subjective analysis using the wrinkle severity scores.

Group Type: OTHER

Fraxel Laser Treatment

Intervention Type: PROCEDURE

The device to be used in this study is a FDA approved device \[510(k) approval\] used for aesthetic dermatological procedures. The Fraxel Repair laser system utilizes a sealed off, all metal carbon dioxide gas tube that is radio frequency (RF) excited and air cooled, emitting light at a wavelength of 10.6 μm with programmable pulse duration and frequency. The Fraxel Repair laser has a continuous motion (rolling) optical tracking system. The Fraxel system consists of a treatment component and an internal control component. The treatment component consists of the laser delivery handpiece. A computer with a touch screen keyboard to enter subjects' information also provides controls for the fractionated delivery of the 10.6 μm beam.

Interventions

Fraxel Laser Treatment

The device to be used in this study is a FDA approved device \[510(k) approval\] used for aesthetic dermatological procedures. The Fraxel Repair laser system utilizes a sealed off, all metal carbon dioxide gas tube that is radio frequency (RF) excited and air cooled, emitting light at a wavelength of 10.6 μm with programmable pulse duration and frequency. The Fraxel Repair laser has a continuous motion (rolling) optical tracking system. The Fraxel system consists of a treatment component and an internal control component. The treatment component consists of the laser delivery handpiece. A computer with a touch screen keyboard to enter subjects' information also provides controls for the fractionated delivery of the 10.6 μm beam.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Healthy male and female adults between 18-75 years of age.
• Subjects who can read, understand, and sign the Informed Consent Form.
• Subjects willing and able to comply with all study requirements.
• Fitzpatrick skin type I-IV (Although the systems are cleared for all skin types I- VI, it is recommended to use the Matrix applicators on skin types I- V).

Exclusion Criteria

• Subjects with active localized or systemic infections.
• Immunocompromised subjects.
• Subjects with coagulation disorder.
• History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
• Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
• In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
• Use of Accutane® within the past 6 months.
• Subjects with a history of radiation therapy to the treatment area.
• Subject has a history of allergy to lidocaine or ester-based local anesthetics.
• Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
• Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Valeant Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey M. Kenkel, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center Dept. of Plastic Surgery

Dallas, Texas, United States

Countries

United States

Other Identifiers

Fraxel Laser for Upper Lip

Identifier Type: -

Identifier Source: org_study_id