CLINICAL TRIALS PROFILE FOR HIBICLENS

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	Unknown status	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).

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 Pre Operative Skin Preparations	Completed	CareFusion	Phase 3	2007-11-13	Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.

Clinical Trial Conditions for Hibiclens

Condition Name

Condition Name for Hibiclens
Intervention	Trials
Staphylococcal Skin Infections	3
Staphylococcus Aureus	3
Furunculosis	2

Condition MeSH

Condition MeSH for Hibiclens
Intervention	Trials
Infections	6
Infection	5
Staphylococcal Infections	5

Clinical Trial Locations for Hibiclens

Trials by Country

Trials by Country for Hibiclens
Location	Trials
United States	15

Trials by US State

Trials by US State for Hibiclens
Location	Trials
Missouri	4
Maryland	2
Tennessee	2
Virginia	2
Washington	1

Clinical Trial Progress for Hibiclens

Clinical Trial Phase

Clinical Trial Phase for Hibiclens
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Hibiclens
Clinical Trial Phase	Trials
Completed	8
Recruiting	3
Unknown status	2

Clinical Trial Sponsors for Hibiclens

Sponsor Name

Sponsor Name for Hibiclens
Sponsor	Trials
Washington University School of Medicine	3
Johns Hopkins University	2
Robert Wood Johnson Foundation	1

Sponsor Type

Sponsor Type for Hibiclens
Sponsor	Trials
Other	21
Industry	2
U.S. Fed	1