Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ChloraPrep Hi-Lite Orange · 1 trial · 1 indication
On the abdominal region a responder was a subject with a 2 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. On the inguinal region a responder was a subject with a 3 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline.
| Arm | Type | Description |
|---|---|---|
| ChloraPrep Hi-Lite Orange | ACTIVE_COMPARATOR | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| Normal Saline | PLACEBO_COMPARATOR | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| 3M CHG/IPA Prep Tint 10.5 mL | EXPERIMENTAL | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| 3M CHG/IPA Prep Tint 26-mL | EXPERIMENTAL | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| Name | Type | Description |
|---|---|---|
| ChloraPrep Hi-Lite Orange | DRUG | Apply topically. |
| Normal saline | DRUG | Apply topically. |
| 3M CHG/IPA Prep Tint 10.5-mL | DRUG | Apply topically. |
| 3M CHG/IPA Prep Tint 26-mL | DRUG | Apply topically |
Inclusion Criteria: * Subjects of any race * Subjects in good general health * Minimum skin flora baseline requirements on abdomen and groin Exclusion Criteria: * Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test are...
ChloraPrep Hi-Lite Orange is used for bacterial reduction on skin flora after product application. It is an investigational small molecule being studied in infectious disease. The product is intended to reduce bacteria on the skin, which is relevant for pre-operative patient preparation.
ChloraPrep Hi-Lite Orange is being developed by Solventum Corporation, traded as SOLV on the stock exchange. The company is conducting clinical research on this product for bacterial reduction on skin flora.
ChloraPrep Hi-Lite Orange is in Phase 3 clinical development. It is an investigational product, not yet approved by regulatory authorities. The Phase 3 trial has been completed, and the product remains under clinical investigation.
ChloraPrep Hi-Lite Orange has one completed Phase 3 trial, NCT01968707, titled 'In-vivo Efficacy Study of Patient Pre-operative Preps'. This randomized, placebo-controlled study enrolled 426 participants in the United States to evaluate bacterial reduction on skin flora.
ChloraPrep Hi-Lite Orange is not FDA approved. It is an investigational product currently in Phase 3 clinical development. The completed trial NCT01968707 evaluated its efficacy, but regulatory approval has not been granted.
ChloraPrep Hi-Lite Orange is a small molecule designed to reduce bacteria on the skin. Its specific molecular target has not been disclosed. The product is being studied for its ability to lower skin flora bacterial counts after application.