Ignite Creation Date:
2024-05-06 @ 5:46 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05423613
Status:
RECRUITING
Last Update Posted:
2023-07-11
First Post:
2022-06-02
Brief Title:
Microneedling for Burn Hypertrophic Scars
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Patients will receive microneedling once every six weeks for a maximum of five treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None