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Last Updated: August 6, 2020

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CLINICAL TRIALS PROFILE FOR HIBICLENS

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505(b)(2) Clinical Trials for Hibiclens

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04021524 BPO vs Hibiclens Soap for Surgical Preparation Active, not recruiting University of Washington Phase 4 2018-09-10 This is a randomized trial of benzoyl peroxide soap versus Hibiclens soap for surgical preparation. The objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, Hibiclens soap (chlorhexidine gluconate), in reducing loads of Propionibacteria (Propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Hibiclens

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00513799 The Natural History of Community-Associated MRSA Infections and Decolonization Strategies Completed Washington University School of Medicine N/A 2007-03-01 The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus. In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.
NCT00731783 Staphylococcus Aureus Decolonization Study Completed Washington University School of Medicine N/A 2008-07-01 The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.
NCT00799812 Test for Preoperative Skin Preparations Completed CareFusion Phase 1/Phase 2 2007-11-01 Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used one-at-a-time. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile water) applied using the same method as the ChloraPrep Swabstick.
NCT01196169 Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty Terminated Cubist Pharmaceuticals LLC Phase 4 2010-10-01 This study will evaluate the safety and effectiveness of daptomycin, an antibiotic compared to another one which is vancomycin when given around the time of joint replacement surgery. Vancomycin is recommended for perioperative prophylaxis in methicillin resistant Staphylococcus aureus (MRSA) colonized patients undergoing primary total joint arthroplasty. Daptomycin has not been recommended for this indication but it is FDA approved for treatment of MRSA blood stream and skin and soft tissue infections. Data collected during this study may support the use of daptomycin for this indication and may also be used for other research purposes that have not yet been specified.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Hibiclens

Condition Name

Condition Name for Hibiclens
Intervention Trials
Staphylococcus Aureus 3
Staphylococcal Skin Infections 3
Abscesses 2
Methicillin-Resistant Staphylococcus Aureus 2
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Condition MeSH

Condition MeSH for Hibiclens
Intervention Trials
Infection 5
Communicable Diseases 4
Staphylococcal Infections 4
Staphylococcal Skin Infections 3
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Clinical Trial Locations for Hibiclens

Trials by Country

Trials by Country for Hibiclens
Location Trials
United States 11
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Trials by US State

Trials by US State for Hibiclens
Location Trials
Missouri 3
Maryland 2
Tennessee 2
Washington 1
New York 1
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Clinical Trial Progress for Hibiclens

Clinical Trial Phase

Clinical Trial Phase for Hibiclens
Clinical Trial Phase Trials
Phase 4 5
Phase 2 1
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Hibiclens
Clinical Trial Phase Trials
Completed 4
Recruiting 3
Active, not recruiting 2
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Clinical Trial Sponsors for Hibiclens

Sponsor Name

Sponsor Name for Hibiclens
Sponsor Trials
Washington University School of Medicine 3
Case Western Reserve University 1
Johns Hopkins University 1
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Sponsor Type

Sponsor Type for Hibiclens
Sponsor Trials
Other 16
Industry 2
U.S. Fed 1
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