Microneedling for Burn Hypertrophic Scars
Primary Purpose
Burn Scar
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Microneedling
Sponsored by
About this trial
This is an interventional treatment trial for Burn Scar
Eligibility Criteria
Inclusion Criteria:
- Any gender or race
- 16 years of age or older
- Have at least 2 HSc that meet the clinical criteria for HSc
- Provide written informed consent.
Exclusion Criteria:
- Patients with keloid scars
- Mature scar site
- A psychiatric condition or cognitive impairment that interferes with their ability to follow the treatment protocol
- Dermatological conditions (i.e. psoriasis, eczema, etc.) in the area of the evaluation site
- An allergy to ultrasound gel
- On anticoagulant medications
- Inability to understand English or French.
Sites / Locations
- Villa Medica Rehabilitation HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Microneedling treated scar
Control scar
Arm Description
Microneedling
No intervention, standard of care
Outcomes
Primary Outcome Measures
Skin Erythema Changes
Erythema index measure by Mexameter, values from 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Cutometer Skin Elasticity Changes
Skin elasticity measures (r0- Cutometer), mm
Skin Thickness Changes
Ultrasound skin measures, mm
Secondary Outcome Measures
Patient reported effectiveness of intervention
Visual analog scale (score 0-none to 10-worse)
Full Information
NCT ID
NCT05423613
First Posted
June 2, 2022
Last Updated
July 10, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT05423613
Brief Title
Microneedling for Burn Hypertrophic Scars
Official Title
Randomized Controlled Evaluator-blinded Trial of Microneedling for the Treatment of Hypertrophic Scars of Adult Burn Survivors and Patients With Severe Skin Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
June 20, 2025 (Anticipated)
Study Completion Date
June 20, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Approximately 33 to 91% of severe burn victims will develop hypertrophic scars. Hypertrophic scars are defined as erythematous (red), raised and rigid scars that can cause pain and itching, among other things. They cause psychological distress and affect the quality of life of burn victims. Microneedling is a technique that uses an electrical device to create hundreds of microchannels that penetrate the skin layers. This study is interested in determining the effectiveness of microneedling in improving the pliability, thickness and erythema of hypertrophic scars. Each scar will receive up to 5 ACS-pen treatments followed by the application of cortisone (triamcinolone acetonide). Knowing that microneedling increases the absorption of products applied to the skin by about 80%, it is logical to think that creating these channels to the dermis and applying cortisone afterwards would have a beneficial effect on the hypertrophic scars of these patients.
Detailed Description
Patients will receive microneedling once every six weeks for a maximum of five treatments
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microneedling treated scar
Arm Type
Experimental
Arm Description
Microneedling
Arm Title
Control scar
Arm Type
No Intervention
Arm Description
No intervention, standard of care
Intervention Type
Procedure
Intervention Name(s)
Microneedling
Intervention Description
A 5% lidocaine anesthetic cream will be applied to the scar to be treated and will be wrapped with an occlusive dressing (saran wrap) for 30 minutes prior to the procedure. The same scar will be subjected to the ACS-Pen treatment at a depth of 1.5 mm or less depending on the results of the thickness measurement performed prior to treatment. Within 5 minutes after the microneedling treatment, a thin layer of triamcinolone acetonide and 2% xylocaine (1:3 ratio) suspension will be spread over the scar. The physician will then gently massage the product into the microneedling columns. The same amount will be used for each subsequent treatment. The patient will also be given a small amount of hydrocortisone 2.5% (low potency corticosteroid) to be applied to the treated site at 12 hours and 24 hours post-treatment.
Primary Outcome Measure Information:
Title
Skin Erythema Changes
Description
Erythema index measure by Mexameter, values from 0 to 999. The erythema values are individual for each person and depend strongly on the ethnic group. The measurements are generally used to determine changes before and after a treatment.
Time Frame
Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Title
Cutometer Skin Elasticity Changes
Description
Skin elasticity measures (r0- Cutometer), mm
Time Frame
Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Title
Skin Thickness Changes
Description
Ultrasound skin measures, mm
Time Frame
Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
Patient reported effectiveness of intervention
Description
Visual analog scale (score 0-none to 10-worse)
Time Frame
Baseline, 12 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Any gender or race
16 years of age or older
Have at least 2 HSc that meet the clinical criteria for HSc
Provide written informed consent.
Exclusion Criteria:
Patients with keloid scars
Mature scar site
A psychiatric condition or cognitive impairment that interferes with their ability to follow the treatment protocol
Dermatological conditions (i.e. psoriasis, eczema, etc.) in the area of the evaluation site
An allergy to ultrasound gel
On anticoagulant medications
Inability to understand English or French.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bernadette Nedelec
Phone
514-398-1275
Email
bernadette.nedelec@mcgill.ca
Facility Information:
Facility Name
Villa Medica Rehabilitation Hospital
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernadette Nedelec
Email
bernadette.nedelec@mcgill.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Microneedling for Burn Hypertrophic Scars
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