Microneedling for Burn Hypertrophic Scars

Study Overview
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Brief Summary
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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
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Patients will receive microneedling once every six weeks for a maximum of five treatments

Official Title
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Randomized Controlled Evaluator-blinded Trial of Microneedling for the Treatment of Hypertrophic Scars of Adult Burn Survivors and Patients With Severe Skin Disorders

Conditions
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Burn Scar

Intervention / Treatment
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* Procedure: Microneedling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Microneedling treated scar<br>Microneedling | Procedure: Microneedling<br>* 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.<br>|
| No Intervention: Control scar<br>No intervention, standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks | 
| Cutometer Skin Elasticity Changes | Skin elasticity measures (r0- Cutometer), mm | Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks | 
| Skin Thickness Changes | Ultrasound skin measures, mm | Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported effectiveness of intervention | Visual analog scale (score 0-none to 10-worse) | Baseline, 12 weeks post intervention |