NCT04495920

Clinical Evaluation of the Residual Antimicrobial Activity

Clinical Evaluation of the Residual Antimicrobial Activity of One Test Product Based on the ASTM E2752 Test Method

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: CAGE Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the residual antimicrobial efficacy of one test product as defined by the difference between the number of a challenge bacterial species recovered following exposure to the test product and the number recovered when untreated (negative control). The challenge bacterial species to be used is Staphylococcus aureus (ATCC #6538) (S. aureus). Testing will be carried out using a modification of the standardized test method described in ASTM E2752-10 (2015) Standard Guide for Evaluation of Residual Effectiveness of Antibacterial Personal Cleansing Products. Bacterial recoveries will be assayed after application oftest material, using the forearms as a substrate.

Detailed description

At least twelve test subjects (aged 18-65 years), with healthy skin will be used in this study, and will use the test product on one arm, and have the other arm untreated as the negative control. The test sites on both forearms will be inoculated with suspensions containing Staphylococcus au re us (A TCC #653 8), immediately after the 30 minute product drying time, and at approximately 2 hours and 4 hours following test material applications. The test sites will be sampled using the cup scrub procedure approximately 20 minutes following each inoculation. The log 10 microbial recoveries of treated versus untreated sites will be the basis for assessing the residual antimicrobial effectiveness of the test product.

Conditions

• Bacterial Overgrowth

Interventions

Type	Name	Description
DRUG	CGB-S-100	Alcohol and choline geranate

Timeline

• Start date: 2020-06-16
• Primary completion: 2020-07-13
• Completion: 2020-07-28
• First posted: 2020-08-03
• Last updated: 2020-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study