Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04582305
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-09
First Post:
2020-10-05
Brief Title:
Bleomycin Jet Injections in Keloids
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Intralesional Bleomycin Treatment of Keloids Using an Electronic Pneumatic Jet Injector a Double-blind Randomized Placebo-controlled Trial With Split-lesion Design
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
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:
This is a single center double-blind patient and investigator randomized placebo-controlled study with a split-lesion design in which selected keloids will receive three consecutive treatments of a bleomycin and b placebo saline NaCl 09 administered with an electronic pneumatic jet injector
Detailed Description:
This is a single center double-blind patient and investigator randomized placebo-controlled study with a split-lesion designAll study procedures will be performed at the Department of Dermatology Erasmus MC Medical Center in patients referred for scar treatment to our outpatient clinic
Clinical photos will be obtained after signing the informed consent form by patient and investigator Study visits and clinical assessments will be scheduled at baseline 4 weeks 8 weeks and 12 weeks Measurements include clinical photography scar volume measured by 3D-camera POSAS questionnaire laser speckle contrast imaging to visualize keloid scar vascularization measurement of residue formation on the skin and a treatment related questionnaire The keloid will be divided into two treatment areas and randomly assigned to three consecutive treatments of a bleomycin and b placebo saline NaCl 09 administered with an electronic pneumatic jet injector
Clinical photos will be obtained after signing the informed consent form by patient and investigator Study visits and clinical assessments will be scheduled at baseline 4 weeks 8 weeks and 12 weeks Measurements include clinical photography scar volume measured by 3D-camera POSAS questionnaire laser speckle contrast imaging to visualize keloid scar vascularization measurement of residue formation on the skin and a treatment related questionnaire The keloid will be divided into two treatment areas and randomly assigned to three consecutive treatments of a bleomycin and b placebo saline NaCl 09 administered with an electronic pneumatic jet injector
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