Reducing pain and itch in burn scars with laser treatment
Evaluating the Mechanism of Pain and Itch Reduction in Burn Scars Following Fractional Ablative CO2 Laser Treatment
This study is testing if a special laser treatment can help people with painful or itchy burn scars feel better and improve the look of their scars.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04364217 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of fractional CO2 laser therapy on hypertrophic burn scars, focusing on pain and itch reduction. Patients with painful or itchy scars will receive standard laser treatment while also undergoing skin biopsies and completing questionnaires about their symptoms. The study aims to correlate histological changes in the scar tissue with reported symptom relief, enhancing understanding of the treatment's effectiveness. Additionally, photographic documentation will track cosmetic improvements throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates are individuals with hypertrophic burn scars that are painful or itchy, who are planning to undergo laser treatment.
Not a fit: Patients with medical conditions that prevent laser treatment or those who have previously undergone similar procedures on the scar may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide significant relief from pain and itch for patients with hypertrophic burn scars.
How similar studies have performed: While the pain and itch reduction phenomenon is noted in literature, this study aims to provide novel insights through histological evaluation, making it a unique approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Friedstat, MD — Massachusetts General Hospital
- Study coordinator: Nisrine Kawa, MD
- Email: nikawa@mgh.harvard.edu
- Phone: 6177242168
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.