Microneedling for Burn Hypertrophic Scars

Not Applicable

Recruiting

• Conditions: Burn Scar
• Interventions: Procedure: Microneedling

• Registration Number: NCT05423613
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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

Study Timeline

• Study Start: 2021-01-22
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-06-20
• Study Completion: 2026-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microneedling treated scar	Microneedling	Microneedling

Primary Outcome Measures

Name	Time	Method
Skin Erythema Changes	Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks	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	Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks	Skin elasticity measures (r0- Cutometer), mm
Skin Thickness Changes	Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks	Ultrasound skin measures, mm

Secondary Outcome Measures

Name	Time	Method
Patient reported effectiveness of intervention	Baseline, 12 weeks post intervention	Visual analog scale (score 0-none to 10-worse)

Trial Locations

Locations (1)

Villa Medica Rehabilitation Hospital; 🇨🇦 Montréal, Canada