Microneedling for Burn Hypertrophic Scars

NCT05423613 | Active Not Recruiting

• 1 other identifier: 20.184
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn Scar

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Patient reported effectiveness of intervention

  Baseline, 12 weeks post intervention

Study Arms (2)

Microneedling treated scar

EXPERIMENTAL

Microneedling

Procedure: Microneedling

Control scar

NO INTERVENTION

No intervention, standard of care

Interventions

Microneedling PROCEDURE

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.

Microneedling treated scar

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender or race
• years of age or older
• Have at least 2 HSc that meet the clinical criteria for HSc
• Provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Villa Medica Rehabilitation Hospital

Montreal, Canada

Location

MeSH Terms

Interventions

Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, McGill University

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 21, 2022
• Study Start: January 22, 2021
• Primary Completion: July 18, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)