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

NCT04364217 | Withdrawn FDA Device

• 1 other identifier: 2019P003424
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scar; Burn Scar

Keywords

Pain; Itch

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Symptomatic Improvement Assessment

  7 months

Study Arms (1)

Treatment

OTHER

Laser treatment to 3x3cm2 area. It will receive the Luminous ultra pulse fractional ablative carbon dioxide laser at 150mJ, 3% density and 250Hz

Device: Luminis ultrapulse fractional ablative carbon dioxide laser

Interventions

Luminis ultrapulse fractional ablative carbon dioxide laser DEVICE

This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.

Also known as: Fractional CO2 laser treatment

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Pain; Pruritus

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Study Officials

• Jonathan Friedstat, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Surgery

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: April 28, 2020
• Study Start: June 25, 2020
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (1)