Clinical trial NCT04769089: Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.
Official title: Effects of Pulsed Dye and CO2 Laser in Treatment of Hypertrophic Burn Scars.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Scar
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
Collaborators: name: United States Army Institute of Surgical Research
First posted: 2021-02-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of laser treatments
timeFrame: 4-6 weeks post treatment
Secondary outcomes:
measure: Improvement of symptoms
timeFrame: 4-6 weeks post treatment
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: United States Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: Metis Foundation
name: Rodney Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooper LE, Nuutila K, Kemp Bohan PM, Diaz V, Batchinsky M, Carlsson AH, Cancio LC, Chan RK. Analysis of the Utility of CO2 and Pulse-Dye Lasers Together and Separately in the Treatment of Hypertrophic Burn Scars. Ann Plast Surg. 2022 Aug 1;89(2):166-172. doi: 10.1097/SAP.0000000000003240.