Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04756154 | Efficacy Study of Patient Preoperative Preps In-vivo | PHASE3 | COMPLETED | 154 | — | — | Jul 6, 2020 | Apr 28, 2021 | Oct 1, 2024 | 1 | United States |
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
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
| Arm | Type | Description |
|---|---|---|
| CHG/IPA Surgical skin preparation | EXPERIMENTAL | Apply topically to the inguinal region for 2 minutes |
| CHG/IPA Film-Forming Surgical skin preparation | ACTIVE_COMPARATOR | Apply topically to the inguinal region for 2 minutes |
| Normal saline | PLACEBO_COMPARATOR | Apply topically to the inguinal region for 2 minutes |
| Name | Type | Description |
|---|---|---|
| CHG/IPA Surgical skin preparation | DRUG | Apply topically to the inguinal region for 2 minutes |
| Normal saline | DRUG | Apply topically to the inguinal region for 2 minutes |
Inclusion Criteria: * Subjects of any race * Subjects in good health * Minimum skin flora baseline requirements on inguinal region Exclusion Criteria: * Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area * Topica...