WITHDRAWN

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-06-25

Study Completion:2025-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT04364217

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

Jonathan Friedstat, MD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Jonathan Friedstat, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-06-25

Study Completion Date2025-07

Study Record Updates

Study Start Date2020-06-25

Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

Pain
Itch

Additional Relevant MeSH Terms

Hypertrophic Scar
Burn Scar