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

NCT03715049 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2018-10-22

No results posted yet for this study

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.

Conditions

  • Wrinkle

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Valeant Pharmaceuticals

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey M. Kenkel, MD · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715049 on ClinicalTrials.gov