Clinical trial NCT04364217: Pain and Itch Reduction in Burn Scars Treated With Fractional CO2 Laser
Official title: Evaluating the Mechanism of Pain and Itch Reduction in Burn Scars Following Fractional Ablative CO2 Laser Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Scar
Burn Scar
Keywords: Pain
Itch
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Histological change in nerve density
timeFrame: 7 months
measure: Histological change in nerve morphology
timeFrame: 7 months
Secondary outcomes:
measure: Symptomatic Improvement Assessment
timeFrame: 7 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jonathan Friedstat, MD
role: PRINCIPAL_INVESTIGATOR
References: