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COMPLETED NA

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

NCT03715049 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03715049

The ClinicalTrials.gov registry entry for NCT03715049 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 742 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03715049 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03715049?

The interventions under investigation include: Fraxel Laser Treatment (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03715049?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 742 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial