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Last Updated: October 22, 2021

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CLINICAL TRIALS PROFILE FOR CHLORHEXIDINE GLUCONATE

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505(b)(2) Clinical Trials for CHLORHEXIDINE GLUCONATE

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).
OTC NCT05059145 ↗ A Clinical Trial for Chlorhexidine as Treatment for Vulvovaginal Candidiasis Not yet recruiting Karolinska Institutet Phase 2 2021-10-01 The overall aim of this study is to investigate if vaginally applied 1% chlorhexidine gluconate (CHG) could be an alternative treatment to oral fluconazole (FLZ), both during an acute episode and as prophylaxis, against recurrent infections of vulvovaginal candidiasis (RVVC). RVVC is very common in fertile women. Up to six months of treatment with FLZ is recommended for RVVC. Over the last ten years, the use of FLZ has increased markedly in many countries. No major problems have been noted with resistance development, but there is concern that this will occur in the future and alternative treatments are requested. In recent years, it has emerged that flukonazol interacts with several different types of drugs that are common in the patient group; several antidepressants, pain relief at dysmenorrhea (NSAID) and oral contraceptives to name a few. In Sweden an over-the-counter vaginal cream consisting of 1% chlorhexidine gluconate (Hibitane┬«) is available with the indication antiseptic use in vaginal examinations, especially during childbirth. The product has been used for a long time in various gynecological and obstetric surgical procedures. Hibitane┬« is approved during pregnancy and the cream is usually well tolerated. Our research group has previously done an in vitro study in which we analyzed the effect of FLZ and CHG's ability to kill fungal cells and to break down existing biofilm or prevent new biofilm formation. The biofilm formation is an important stage for the fungal cells to attach to surfaces such as skin and mucosa and is considered a first step in the development of an infection. In the biofilm, the fungus can hide from the immune system and also to some extent for various treatments aimed against the fungus. The results of the study showed that CHG was better than FLZ both at killing the fungal cells and preventing new biofilm from forming and dissolving already established "old" biofilm. This effect is absolutely crucial for successful treatment with antimycotics. These encouraging results form the basis of the planned study. If CHG is at least as effective as FLZ with little impact on vaginal lactobacillus, with high tolerability and without cytotoxic effect on epithelial cells, the results of the study might lead to major benefits to the patients with reduced risk of systemic side effects such as drug interactions, development of drug resistance and reduced drug costs.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for CHLORHEXIDINE GLUCONATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002431 ↗ The Safety and Effectiveness of Peridex in Preventing or Delaying Fungal Infections of the Mouth in HIV-Infected Patients Completed Procter and Gamble N/A 1969-12-31 To evaluate the safety and effectiveness of Peridex (an oral rinse containing chlorhexidine gluconate) for preventing the occurrence of clinically-evident microbiologically-documented oral candidiasis in HIV-positive patients, who are at risk of the disease based on previous history of candidiasis.
NCT00123123 ↗ Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 2004-03-01 Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.
NCT00123123 ↗ Effect of Improved Oral Hygiene to Prevent Pneumonia in Hospitalized Patients Completed State University of New York at Buffalo Phase 2 2004-03-01 Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The specific aims of this investigation are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients.
NCT00130221 ↗ Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections Completed Centers for Disease Control and Prevention Phase 1 2005-06-01 Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.
NCT00130221 ↗ Skin Cleansing With Chlorhexidine to Decrease Hospital Acquired Infections Completed Sage Products, Inc. Phase 1 2005-06-01 Patients in the intensive care unit are at risk for many infections because the severity of illness and the procedures necessary to care for them. This study is designed to look at a change in bathing procedure as a method to reduce infections. Currently, patients at John H. Stroger Hospital are cleansed with soap and water. However, preliminary data from a previous study at Rush University Medical Center showed that a chlorhexidine (CHG)-impregnated cloth (2% CHG Antiseptic Cloth system, Sage Products, Inc.) decreased skin bacteria and may lessen bacteria in the blood stream. The 2% CHG Antiseptic Cloth system is a non-irritating, no-rinse, cleansing and moisturizing product that contains 2% chlorhexidine gluconate. The goal of this proposed study is to further evaluate the effectiveness of the 2% CHG Antiseptic Cloth system compared with soap and water in cleansing the skin and preventing bacteria from entering the bloodstream.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CHLORHEXIDINE GLUCONATE

Condition Name

Condition Name for CHLORHEXIDINE GLUCONATE
Intervention Trials
Surgical Site Infection 9
Bacteremia 5
Healthy 3
Gingivitis 3
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Condition MeSH

Condition MeSH for CHLORHEXIDINE GLUCONATE
Intervention Trials
Infection 20
Communicable Diseases 16
Surgical Wound Infection 12
Bacteremia 7
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Clinical Trial Locations for CHLORHEXIDINE GLUCONATE

Trials by Country

Trials by Country for CHLORHEXIDINE GLUCONATE
Location Trials
United States 90
Canada 8
Israel 4
India 4
Turkey 3
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Trials by US State

Trials by US State for CHLORHEXIDINE GLUCONATE
Location Trials
California 8
Michigan 7
New York 7
Illinois 6
Texas 6
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Clinical Trial Progress for CHLORHEXIDINE GLUCONATE

Clinical Trial Phase

Clinical Trial Phase for CHLORHEXIDINE GLUCONATE
Clinical Trial Phase Trials
Phase 4 40
Phase 3 13
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for CHLORHEXIDINE GLUCONATE
Clinical Trial Phase Trials
Completed 45
Recruiting 36
Not yet recruiting 22
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Clinical Trial Sponsors for CHLORHEXIDINE GLUCONATE

Sponsor Name

Sponsor Name for CHLORHEXIDINE GLUCONATE
Sponsor Trials
University of California, San Diego 7
Medline Industries 6
3M 4
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Sponsor Type

Sponsor Type for CHLORHEXIDINE GLUCONATE
Sponsor Trials
Other 123
Industry 28
NIH 4
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