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Microneedling for Burn Scars
N/A
Recruiting
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
16 years of age or older
Must not have
Inability to understand English or French.
Mature scar site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether microneedling, a technique that creates microchannels in the skin, can improve the appearance of hypertrophic scars.
Who is the study for?
This trial is for individuals aged 16 or older with at least two hypertrophic scars from burns, who can consent to treatment. It's not suitable for those with keloid scars, mature scar sites, certain psychiatric or cognitive impairments, skin conditions like psoriasis or eczema near the scar site, allergies to ultrasound gel, language barriers in English or French, or those on anticoagulants.
What is being tested?
The study tests microneedling's effectiveness on burn-related hypertrophic scars. Microneedling involves an electrical device creating microchannels in the skin followed by cortisone application. The goal is to improve scar pliability, thickness and redness through up to five treatments.
What are the potential side effects?
Microneedling may cause temporary redness, swelling at the treatment site and bruising. There might also be a risk of infection due to skin punctures and increased sensitivity due to cortisone application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 16 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot understand English or French.
Select...
My surgical scar has fully healed.
Select...
I am currently taking blood thinner medications.
Select...
I have skin conditions like psoriasis or eczema where the treatment will be applied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, before treatments #3, #4 and #5, post 6 weeks and 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cutometer Skin Elasticity Changes
Skin Erythema Changes
Skin Thickness Changes
Secondary study objectives
Patient reported effectiveness of intervention
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Microneedling treated scarExperimental Treatment1 Intervention
Microneedling
Group II: Control scarActive Control1 Intervention
No intervention, standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Microneedling
2017
Completed Phase 3
~340
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,344 Total Patients Enrolled
2 Trials studying Burn Scars
55 Patients Enrolled for Burn Scars
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot understand English or French.I am 16 years old or older.My surgical scar has fully healed.I am currently taking blood thinner medications.I have skin conditions like psoriasis or eczema where the treatment will be applied.My gender or race does not limit my participation.
Research Study Groups:
This trial has the following groups:- Group 1: Control scar
- Group 2: Microneedling treated scar
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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