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

The Metis Foundation

Status: Completed

Conditions: Hypertrophic Scar

Treatments: Procedure: Treatment with CO2 Laser; Other: Control; Procedure: Treatment with Pulse Dye Laser; Procedure: Treatment with combination of pulse dye laser and CO2 laser.

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04769089

M-10590

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 4 patient groups

Pulse Dye Laser

Experimental group

Description:

Treatment with PDL alone.

Treatment:

Procedure: Treatment with Pulse Dye Laser

CO2 Laser

Experimental group

Description:

Treatment with CO2 alone.

Treatment:

Procedure: Treatment with CO2 Laser

Combination

Experimental group

Description:

Treatment with both PDL and CO2 laser.

Treatment:

Procedure: Treatment with combination of pulse dye laser and CO2 laser.

No treatment

Active Comparator group

Description:

No laser treatment.

Treatment:

Other: Control