An interventional study of Treatment with Pulse Dye Laser and Treatment with CO2 Laser in Hypertrophic Scar, sponsored by The Metis Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-24.
Sponsored by The Metis Foundation · Not applicable, Interventional, and Treatment
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.
656 studies on the registry are indexed under Hypertrophy; 87 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 460 interventional studies indexed under Hypertrophy.
Browse Hypertrophy studies →The Metis Foundation is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment with PDL alone.
Procedure: Treatment with Pulse Dye Laser
Treatment with CO2 alone.
Procedure: Treatment with CO2 Laser
Treatment with both PDL and CO2 laser.
Procedure: Treatment with combination of pulse dye laser and CO2 laser.
No laser treatment.
Other: Control
Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.
CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
One area will be randomized to receive no laser treatment.
Effectiveness of laser treatments
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)
Time frame: 4-6 weeks post treatment
Improvement of symptoms
To longitudinally compare the change in symptoms by treatment modality between treatment sessions by assessment with the Patient and Observer Scar Assessment Scale (POSAS) measured for each patient and two observers (to increase score reliability) at each follow-up visit.
Time frame: 4-6 weeks post treatment
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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