Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271993
Status:
COMPLETED
Last Update Posted:
2024-02-23
First Post:
2024-02-15
Brief Title:
SPT for Sensitization of Collagen Dressing
Sponsor:
Covalon Technologies Inc
Organization:
Covalon Technologies Inc
Study Overview
Official Title:
Skin Prick Test SPT for Skin Sensitization Contact Allergy of Test Product ColActive Plus Collagen Matrix Dressing
Status:
COMPLETED
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:
The goal of this clinical trial is to determine the sensitization contact allergy potential of the test product ColActive Plus Collagen Matrix Dressing after a skin prick test on the skin of healthy human subjects The main question it aims to answer is
Does the product induce any sensitization contact allergy after a skin prick using a UniTest PC pain control device in healthy human subjects Participants will have the test product and both positive and negative controls applied and skin response will be evaluated by an allergist at 15 minutes 6 hours and 24-48 hours post-application to see if sensitization occurs
Does the product induce any sensitization contact allergy after a skin prick using a UniTest PC pain control device in healthy human subjects Participants will have the test product and both positive and negative controls applied and skin response will be evaluated by an allergist at 15 minutes 6 hours and 24-48 hours post-application to see if sensitization occurs
Detailed Description:
This will be a single center with no randomization or blinding study design in 30 healthy adult subjects age 18-70 years Based on prior experience approximately 30 subjects will be enrolled to ensure 20 subjects complete the study
Skin response to the test product and both positive and negative controls will be evaluated and measured by an allergist If the measured diameter is 3mm in response to the test product with expected reactions to both the positive and negative controls the site will be considered a positive allergen
Skin response to the test product and both positive and negative controls will be evaluated and measured by an allergist If the measured diameter is 3mm in response to the test product with expected reactions to both the positive and negative controls the site will be considered a positive allergen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None