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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: Completed NA study of Wrinkle, sponsored by University of Texas Southwestern Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome measure of effectiveness will be a paired comparison of baseline to 1, 3, and 6 month follow-up ratings for wrinkles using a Merz Aesthetic Lip Line score (0 none 1-4). Safety will be defined as an absence of hypopigmentary changes and by a restoration of hyperpigmentary changes to mild or less at 1 month. Photographs of treated skin at follow-up visits will be compared to baseline to document the healing time course and may be used for blinded scoring evaluations (0-9 scales
Conditions Studied
Interventions
- PROCEDURE Fraxel Laser Treatment
Study Locations (1)
Texas
- UT Southwestern Medical Center Dept. of Plastic Surgery - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-07 |
| Est. Completion | 2017-12 |
| Phase | NA |
What the finished NCT03715049 record still lists
NCT03715049 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 119-participant average among 25 other Wrinkle trials with a reported enrollment target (71% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03715049's enrollment target sits among peer trials
35 16th of 25 higher than 10 of 25 other Wrinkle trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Wrinkle trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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