Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser

Hypertrophic Scar Clinical Trial

Official title:

Evaluating the Mechanism of Pain and Itch Reduction in Burn Scars Following Fractional Ablative CO2 Laser Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364217
• Other study ID #: 2019P003424
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: Massachusetts General Hospital
• Contact: Nisrine Kawa, MD
• Phone: 6177242168
• Email: nikawa[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hypertrophic Burn Scars (HTBS) are often treated with Fractional CO2 laser therapy to improve cosmetic appearance. It has been noted that this leads to a reduction in the pain and itch associated with this type of scars. While this phenomenon is commonly described in the literature, the mechanism of pain and itch reduction in unclear. The investigators aim to better understand this process by histological evaluation of HTBS at different stages of laser treatment.

Description:

During our study, patients with painful and/or itchy burn scars will undergo standard treatment with fractional CO2 laser. In addition to the standard of care treatment, participants will undergo skin biopsies and be asked to complete Patient Reported Outcome Measure questionnaires related to their HTBS. Burn scars will also undergo standard and 3 dimensional photography at the different stages of treatment. Biopsy samples will undergo various staining techniques to establish the changes in tissue that occur with the laser treatment. This information will also be correlated with the symptomatic changes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: July 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient must have a hypertrophic burn scar treated by skin grafts or allowed to heal secondarily
• Burn must have occurred within the last 2 years from time of recruitment
• Patient must have symptoms of pain and/or itch and/or hypersensitivity in the hypertrophic burn scar area
• Patient must already be planning to undergo laser treatment for their burn scar
• Patient must be willing to undergo biopsy procedures
• Patient must be willing and able to participate in the study with a year of follow-up
• Not be pregnant or planning to become pregnant during the treatment phase of the study

Exclusion Criteria:

• Medical Conditions that preclude laser treatment
• Active tanning, including the use of tanning booths, during the course of the study
• Inability to complete surveys
• Previous laser (PDL, CO2), surgical reconstructive treatment procedures done on the hypertrophic burn scar
• Current treatment with other procedures or drugs (experimental or other) in area of interest
• Medications that interfere with wound healing (oral steroids, immunosuppressive medications, chemotherapy or other)
• Medication for itch (steroids, antihistamines, or other)
• Medication for pain (opioids, topical pain treatment, gabapentin, ondasetron, paroxetine or other)
• Adverse reactions to topical or local anesthetic agents needed for this study, if no alternative to the said agent exists
• The study area should not be part of a contracture or other hypertrophic scar that would be better treated with surgical procedures.
• The study scar must not be adjacent to/in continuity with areas of HTBS that are planning to be treated with surgical interventions.
• Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject
• Patient suffers from epilepsy or seizure disorder.

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix
• Cicatrix, Hypertrophic
• Hypertrophic Scar

Intervention

Device:
• Luminis ultrapulse fractional ablative carbon dioxide laser
This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological change in nerve density	The investigators will stain the collected skin with markers specific to nerves to in order to count the number of nerves per biopsy area.	7 months
Primary	Histological change in nerve morphology	The investigators will stain the collected skin with markers specific to nerves to in order to compare the size and shape of cutaneous nerves before and after treatment. This will be based on subjective evaluation and not a predetermined scale.	7 months
Secondary	Symptomatic Improvement Assessment	Patient Reported Outcome Measures will be collected via the Patient and Observer Scar Assessment Scale (POSAS). This is a validated questionnaire that includes 5 physician-completed parameters and 6 patient-reported measures. Each parameter is rated from 1-10 with a score of 1 representing "skin that appears close to normal" and 10 representing the "worst scare imaginable". Overall, the final score will range from 11( best outcome) to 110 (worst outcome).; Physician parameters relate to the scar appearance such as color and thickness of the scar; while the patient-reported parameters also include symptomatic factors, such as degree of pain associated with the scar	7 months