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Octenidine Dihydrocloride in aqueous

Phase 2

Preoperative Skin Preparation | Small molecule | Dermatology |Becton, Dickinson and Company|Last Updated: Apr 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Clinical trial landscape

Octenidine Dihydrocloride in aqueous · 1 trial · 1 indication

Phase 2 1
NCT03229759Evaluation of the Antimicrobial Effectiveness of an Antimicrobial ClothPreoperative Skin Preparation
COMPLETED99 Analytics
PHASE2COMPLETED
Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth
Preoperative Skin PreparationUnlock trial analytics

Study Endpoints

Primary Endpoints

Bacterial Count at 10 Minutes Post Application
10 minutes after application of test product
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Investigational ProductEXPERIMENTALPolyester cloth impregnated with investigational product
Vehicle Control (VC)PLACEBO_COMPARATORPolyester cloth impregnated with the vehicle control
Saline Control (SC)PLACEBO_COMPARATORSaline applied wtih polyester cloth

Interventions

NameTypeDescription
Octenidine Dihydrocloride in aqueous solutionDRUGapplication of investigational product
Vehicle ControlOTHERapplication of vehicle control
Saline ControlOTHERapplication of placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males and/or females, at least 18 years or older and of any race. * Are in good general health. * Unable to become pregnant, or willing to use an acceptable method of contraception (i.e. oral contraception, intra-uterine device \[IUD\], diaphragm, condom, abstinence, bilateral...

Countries:United States
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Frequently asked questions about Octenidine Dihydrocloride in aqueous

What is Octenidine Dihydrocloride in aqueous used for?

Octenidine Dihydrocloride in aqueous is used for preoperative skin preparation, a dermatology indication. It is being developed as an antimicrobial cloth to reduce skin bacteria before surgical procedures. The drug is currently in Phase 2 clinical development and is being studied in a completed clinical trial in the United States.

Who makes Octenidine Dihydrocloride in aqueous?

Octenidine Dihydrocloride in aqueous is being developed by Becton, Dickinson and Company, which trades under the ticker BDX. The company is conducting clinical research on this small molecule for preoperative skin preparation. The drug is currently in Phase 2 development.

What phase is Octenidine Dihydrocloride in aqueous in?

Octenidine Dihydrocloride in aqueous is in Phase 2 clinical development. It is an investigational drug for preoperative skin preparation and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is Octenidine Dihydrocloride in aqueous in?

Octenidine Dihydrocloride in aqueous has one completed clinical trial, NCT03229759, titled 'Evaluation of the Antimicrobial Effectiveness of an Antimicrobial Cloth.' This Phase 2 study enrolled 99 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.

Is Octenidine Dihydrocloride in aqueous FDA approved?

Octenidine Dihydrocloride in aqueous is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for preoperative skin preparation. The drug has completed one clinical trial, but it has not yet received regulatory approval for marketing.