The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2. Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used. Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
154
Apply topically to the inguinal region for 2 minutes
Apply topically to the inguinal region for 2 minutes
Microbac Laboratories, Inc
Sterling, Virginia, United States
Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes
Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora
Time frame: 10 minutes
Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours
Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora
Time frame: 6 hours
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