Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512274
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2020-08-11
Brief Title:
Skin Protectant Properties of Omeza Collagen Matrix on Damaged Skin
Sponsor:
Omeza LLC
Organization:
Omeza LLC
Study Overview
Official Title:
A Single Center Study in 22 Healthy Male and Female Subjects to Investigate the Skin Protectant and Anti-Inflammatory Properties of Omeza Collagen Matrix on Damaged Skin
Status:
COMPLETED
Status Verified Date:
2022-09
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:
Single-blind within subject comparison study conducted to investigate the skin protectant properties of Omeza Collagen Matrix on damaged skin
Detailed Description:
This study was conducted in 22 healthy subjects to determine the skin protectant and anti-inflammatory properties of the test product
For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings
An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article The test article was applied for 10 minutes at the site of inflammation The test site was then graded for irritation and TEWL readings
For the skin protectant assay the test article was applied to the forearm and covered with gauze for 10 minutes before assessment of irritation and TEWL readings
An inflammatory skin response was induced by a SLS solution 24 hours prior to application of the test article The test article was applied for 10 minutes at the site of inflammation The test site was then graded for irritation and TEWL readings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None