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NCT04769089 · ClinicalTrials.gov registry record · NA
Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.
A NA study of Hypertrophic Scar, sponsored by The Metis Foundation.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04769089: Completed NA study of Hypertrophic Scar, sponsored by The Metis Foundation.
NCT04769089 is a NA study of Hypertrophic Scar that has completed, run by The Metis Foundation. The registered enrollment target is 25 participants, below the 41-participant average among 7 other Hypertrophic Scar trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04769089, a NA study of Hypertrophic Scar, has completed, sponsored by The Metis Foundation.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. Additionally, the Patient Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using two trained, blinded observers. The patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.
Primary Outcome
Using the Patient and Observer Scar Assessment Scale (POSAS), evaluate the effectiveness of Pulse Dye Laser (PDL) and Carbon Dioxide (CO2) laser treatment on symptoms related to Hypertrophic Burn Scar (HBS)
Conditions Studied
Interventions
- OTHER Control
- PROCEDURE Treatment with Pulse Dye Laser
- PROCEDURE Treatment with CO2 Laser
- PROCEDURE Treatment with combination of pulse dye laser and CO2 laser.
Study Locations (1)
Texas
- United States Army Institute of Surgical Research - Fort Sam Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2017-12-19 |
| Est. Completion | 2020-06-24 |
| Phase | NA |
What the finished NCT04769089 record still lists
NCT04769089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 41-participant average among 7 other Hypertrophic Scar trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Hypertrophic Scar appearing as the primary indexed condition, and to 4 interventions - of which Control is the first listed.
NCT04769089 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04769089 about?
NCT04769089 is a clinical study titled "Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.". A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total,...
What is the current status of trial NCT04769089?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2017-12-19. Estimated completion is 2020-06-24.
What conditions does trial NCT04769089 study?
This clinical trial studies the following conditions: Hypertrophic Scar.
What interventions are being tested in trial NCT04769089?
The interventions under investigation include: Control (OTHER), Treatment with Pulse Dye Laser (PROCEDURE), Treatment with CO2 Laser (PROCEDURE), Treatment with combination of pulse dye laser and CO2 laser. (PROCEDURE).
Who is sponsoring clinical trial NCT04769089?
This trial is sponsored by The Metis Foundation, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04769089 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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