Microneedling for Burn Hypertrophic Scars

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

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.

Study Overview

• Status: Recruiting
• Conditions: Burn Scar
• Intervention / Treatment: Procedure: Microneedling

Detailed Description

Patients will receive microneedling once every six weeks for a maximum of five treatments

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernadette Nedelec; Phone Number: 514-398-1275; Email: bernadette.nedelec@mcgill.ca

Study Locations

• Canada
  • Montréal, Canada
    • Recruiting
    • Villa Medica Rehabilitation Hospital
    • Contact: Bernadette Nedelec; Email: bernadette.nedelec@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microneedling treated scar; Microneedling	Procedure: Microneedling; 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.
No Intervention: Control scar; No intervention, standard of care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Estimated): June 20, 2025
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Fibrosis; Cicatrix; Burns; Cicatrix, Hypertrophic
• Other Study ID Numbers: 20.184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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