NCT05423613

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 16 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Burn Scar

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-22
• Primary completion: 2025-07-18
• Completion: 2026-07-31
• First posted: 2022-06-21
• Last updated: 2026-03-18

Locations

1 site across 1 country: Canada