Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
Primary Purpose
Burns
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laser treatment
Sponsored by
About this trial
This is an interventional treatment trial for Burns
Eligibility Criteria
Inclusion Criteria:
- Fitzpatrick skin type <IV (37),
- Have sustained a thermal burn injury,
- Have at least 2 independent sites that show clinical evidence of HSc,
- Are 2 months or more post-injury.
Exclusion Criteria:
- Subjects with skin phototypes IV or higher,
- With history of keloidal scarring,
- Who have coagulation disorder,
- Are taking immunosuppressive medications,
- If the mechanism of injury is an electrical, chemical, or cold injury,
- Any underlying active skin disease,
- Have taken oral Isotreinoin within the last 6 months,
- Photosensitivity or have taken photosensitizing medications,
- Pregnancy,
- Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Laser treated HSc scar
Control scar
Arm Description
Co2 laser treatment
Standard care
Outcomes
Primary Outcome Measures
Skin Characteristics changes
Erythema, elasticity and thickness measures
Secondary Outcome Measures
Satisfaction Questionnaire
Questionnaire
Full Information
NCT ID
NCT03240718
First Posted
February 3, 2017
Last Updated
August 15, 2017
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT03240718
Brief Title
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
Official Title
Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.
Detailed Description
Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser treated HSc scar
Arm Type
Experimental
Arm Description
Co2 laser treatment
Arm Title
Control scar
Arm Type
No Intervention
Arm Description
Standard care
Intervention Type
Procedure
Intervention Name(s)
Laser treatment
Intervention Description
CORE fractional CO2 laser treatment
Primary Outcome Measure Information:
Title
Skin Characteristics changes
Description
Erythema, elasticity and thickness measures
Time Frame
baseline, 12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Satisfaction Questionnaire
Description
Questionnaire
Time Frame
baseline, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fitzpatrick skin type <IV (37),
Have sustained a thermal burn injury,
Have at least 2 independent sites that show clinical evidence of HSc,
Are 2 months or more post-injury.
Exclusion Criteria:
Subjects with skin phototypes IV or higher,
With history of keloidal scarring,
Who have coagulation disorder,
Are taking immunosuppressive medications,
If the mechanism of injury is an electrical, chemical, or cold injury,
Any underlying active skin disease,
Have taken oral Isotreinoin within the last 6 months,
Photosensitivity or have taken photosensitizing medications,
Pregnancy,
Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernadette Nedelec, PhD
Organizational Affiliation
CRCHUM
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
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