Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-02-12 @ 7:38 AM
Study NCT ID:
NCT04035161
Status:
COMPLETED
Last Update Posted:
2021-08-17
First Post:
2019-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Antimicrobial Effectiveness of CHG/IPA
Sponsor:
Becton, Dickinson and Company
Organization:
Study Overview
Official Title:
Evaluation of the Antimicrobial Effectiveness of CHG/IPA in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2021-07
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 single site study is a randomized, controlled, partially-blinded design enrolling a minimum of 516 healthy volunteers, where each subject will receive two of the planned study products on the product application sites of the abdomen and/or groin.
Detailed Description:
To demonstrate the antimicrobial activity of the Investigational Product (IP) by comparing counts of resident skin microbes, obtained after IP application to intact skin of the abdomen and groin, to counts obtained prior to application.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: