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Active, Not Recruiting

NCT Number: NCT05423613

Microneedling for Burn Hypertrophic Scars

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Burn Scar

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Villa Medica Rehabilitation Hospital

Montreal, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Skin Erythema Changes

    Time frame: 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.

  2. Cutometer Skin Elasticity Changes

    Time frame: Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks

    Skin elasticity measures (r0- Cutometer), mm

  3. Skin Thickness Changes

    Time frame: Baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks

    Ultrasound skin measures, mm

Secondary outcomes

  1. Patient reported effectiveness of intervention

    Time frame: Baseline, 12 weeks post intervention

    Visual analog scale (score 0-none to 10-worse)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 21, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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