Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.

Hypertrophic Scar Clinical Trial

Official title:

Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769089
• Other study ID #: M-10590
• Status: Completed
• Phase: N/A
• Start date: December 19, 2017
• Est. completion date: June 24, 2020

Study information

• Verified date: February 2021
• Source: The Metis Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser.

2. Timing: There has been a minimum of 1 month after burn closure

3. The subject is at least 18 years of age and not older than 65.

4. Able and willing to provide verbal and written consent.

Exclusion Criteria:

1. Active infection in experimental area

2. Use of isotretinoin (Accutane) in last six months

3. Life or limb-threatening injury/disease

4. Prior history of non-compliance with medical regimes

5. Active drug use/abuse

6. Active psychiatric illness except depression (unless being treated for suicidal intentions)

7. Pregnancy

8. Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell carcinoma, melanoma and squamous cell carcinoma, as long as the subject is disease free at the time of enrollment.

9. Prior PDL or other laser treatment of the study area.

10. Patient unable to tolerate laser procedure.

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Procedure:
• Treatment with Pulse Dye Laser
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.
• Treatment with CO2 Laser
CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
• Treatment with combination of pulse dye laser and CO2 laser.
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.

Other:
• Control
One area will be randomized to receive no laser treatment.

Locations

Country	Name	City	State
United States	United States Army Institute of Surgical Research	Fort Sam Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Metis Foundation	United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	4-6 weeks post treatment
Secondary	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.	4-6 weeks post treatment