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3M CHG/IPA Prep C

Phase 3

Bacterial Reduction Post-product Application | Small molecule | Infectious Disease |3M Company|Last Updated: Nov 23, 2020

Success Probability
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Market & Valuation
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Trial Design
RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment738
FDA Designations
No designations recorded
Clinical trial landscape

3M CHG/IPA Prep C · 1 trial · 1 indication

Phase 3 1
NCT02203591In Vivo Efficacy Study of Patient Preoperative PrepsBacterial Reduction Post-product Application
COMPLETED738 Analytics
PHASE3COMPLETED
In Vivo Efficacy Study of Patient Preoperative Preps
Bacterial Reduction Post-product Application
NCT02203591738
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Study Endpoints
Primary Endpoints
Responder Rate
baseline, 10 minutes post-product application and 6 hours post-product application

On the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.

Alternative Primary
Baseline and 10 minutes

10 minute log reduction

Secondary Endpoints
Reduction of Skin Flora 6 Hours Post-treatment
6 hours
Reduction of Skin Flora 10 Minutes Post-treatment
10 minutes
Skin Flora Recovery 6-hours Post-treatment
6 hours post-treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
3M CHG/IPA Prep CEXPERIMENTALApply 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 CHEXPERIMENTALApply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
ChloraPrepACTIVE_COMPARATORApply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Normal SalinePLACEBO_COMPARATORApply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Interventions
NameTypeDescription
3M CHG/IPA Prep CDRUGApply 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 CHDRUGApply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
ChloraPrepDRUGApply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Normal SalineDRUGApply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects of any race * Subjects in good 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 area * Topi...

Countries:United States
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