Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CHG/IPA Surgical skin preparation · 1 trial · 1 indication
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...
CHG/IPA Surgical skin preparation is used for surgical skin preparation, which is the process of cleaning and disinfecting a patient's skin before surgery to reduce the risk of infection. It is being developed by Solventum Corporation for use in this dermatology-related indication.
CHG/IPA Surgical skin preparation is being developed by Solventum Corporation, which trades under the ticker SOLV. The company is conducting clinical research on this product for surgical skin preparation.
CHG/IPA Surgical skin preparation is in Phase 3 clinical development. It is an investigational product and has not been approved by regulatory authorities. One Phase 3 trial has been completed, with 154 participants enrolled.
CHG/IPA Surgical skin preparation has one completed Phase 3 trial, NCT04756154, titled "Efficacy Study of Patient Preoperative Preps In-vivo." This randomized, placebo-controlled study enrolled 154 healthy volunteers aged 18 years and older in the United States.
CHG/IPA Surgical skin preparation is a combination product containing chlorhexidine gluconate (CHG) and isopropyl alcohol (IPA), which are common antiseptic agents used for skin preparation before surgery. The product name reflects these active ingredients.