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3M CHG/IPA Prep · 2 trials · 3 indications
The primary measure of efficacy is change in skin flora log10 CFU/cm\^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm\^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at 3 defined post-treatment sampling times.
| Arm | Type | Description |
|---|---|---|
| 3M CHG/IPA Prep / Center | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. |
| 3M CHG/IPA Prep / Mid-peripheral | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area. |
| 3M CHG/IPA Prep / Peripheral | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area. |
| 3M CHG/IPA Prep | EXPERIMENTAL | Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. |
| ChloraPrep | ACTIVE_COMPARATOR | Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. |
| Name | Type | Description |
|---|---|---|
| 3M CHG/IPA Prep | DRUG | Apply topically to intact skin |
| ChloraPrep | DRUG | Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes. |
Inclusion Criteria: * Male subjects of any race who are at least 18 years of age, * Subjects must have an area on their back region to accommodate the treatment coverage area, * Subjects must be in good general health, * Subjects who satisfy all inclusion/exclusion criteria and will voluntarily rea...
3M CHG/IPA Prep is an investigational small molecule being studied for bacterial recovery of skin flora post-product application and as a surgical skin preparation. It is in Phase 2 clinical development for these dermatology indications.
3M CHG/IPA Prep is being developed by Solventum Corporation, which trades under the ticker SOLV.
3M CHG/IPA Prep is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA.
3M CHG/IPA Prep has been studied in two completed Phase 2 trials. NCT03155178 evaluated bacterial recovery of skin flora post-product application in 69 participants. NCT03681990 evaluated surgical skin preparation in 28 male participants in Romania.
3M CHG/IPA Prep is a chlorhexidine gluconate and isopropyl alcohol preparation. The name 3M CHG/IPA Prep refers to this specific investigational product being developed by Solventum Corporation.