Microneedling for Burn Hypertrophic Scars

Burn Scar Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05423613
• Other study ID #: 20.184
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: June 20, 2026

Study information

• Verified date: July 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Bernadette Nedelec
• Phone: 514-398-1275
• Email: bernadette.nedelec[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: June 20, 2026
• Est. primary completion date: June 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Cicatrix, Hypertrophic

Intervention

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.

Locations

Country	Name	City	State
Canada	Villa Medica Rehabilitation Hospital	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cutometer Skin Elasticity Changes	Skin elasticity measures (r0- Cutometer), mm	Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Primary	Skin Thickness Changes	Ultrasound skin measures, mm	Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Secondary	Patient reported effectiveness of intervention	Visual analog scale (score 0-none to 10-worse)	Baseline, 12 weeks post intervention