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NCT03715049 · ClinicalTrials.gov registry record · NA

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

A NA study of Wrinkle, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
NA
Development phase
35
Enrollment target
1
Study location

NCT03715049 is a NA study of Wrinkle that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 35 participants, below the 119-participant average among 25 other Wrinkle trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03715049, a NA study of Wrinkle, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
NA
Development phase
35 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • PROCEDURE Fraxel Laser Treatment

Study Locations (1)

Texas

  • UT Southwestern Medical Center Dept. of Plastic Surgery - Dallas

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2013-07
Est. Completion 2017-12
Phase NA

What the Registry Record Tells You About NCT03715049

The ClinicalTrials.gov registry entry for NCT03715049 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 119-participant average among 25 other Wrinkle trials with a reported enrollment target (71% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Wrinkle appearing as the primary indexed condition, and to 1 intervention - of which Fraxel Laser Treatment is the first listed.

NCT03715049 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT03715049 about?

NCT03715049 is a clinical study titled "Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles". 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 l...

What is the current status of trial NCT03715049?

This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2013-07. Estimated completion is 2017-12.

What conditions does trial NCT03715049 study?

This clinical trial studies the following conditions: Wrinkle.

What interventions are being tested in trial NCT03715049?

The interventions under investigation include: Fraxel Laser Treatment (PROCEDURE).

Who is sponsoring clinical trial NCT03715049?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03715049 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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