Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876546
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-04-27
Brief Title:
Evaluation of Skin Irritancy and Sensitization of a Liquid Bandage
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
Assessment of the Primary Accumulated Irritability and Skin Sensitization Potential of an Elastic Collodion-based Liquid Bandage Under Controlled and Maximized Conditions RIPT
Status:
NOT_YET_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:
The investigational product constitutes a medical device that is freely accessible to consumers and as such must be safe under real or reasonably foreseeable conditions of use and its safety must be tested before being placed on the market
Therefore this study was designed to evaluate the biocompatibility of the experimental product as provided for in legislation
Therefore this study was designed to evaluate the biocompatibility of the experimental product as provided for in legislation
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None