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Last Updated: May 28, 2022

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
New Formulation NCT01349140 ↗ EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed Pacira Pharmaceuticals, Inc Phase 1 2012-02-01 EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation NCT01349140 ↗ EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks Completed University of California, San Diego Phase 1 2012-02-01 EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
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).
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.
NCT00006075 ↗ A Study of Chlorhexidine in the Prevention of HIV-1 Transmission From Mothers to Their Babies Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 The purpose of this study is to find the best strength of chlorhexidine (a solution that kills germs), for washing the mother's vagina during labor and the newborn baby, that may reduce the chance of HIV being passed from an HIV-positive mother to the baby. When used as a wash on the vagina during labor, and on a newborn shortly after birth, a higher dose of chlorhexidine is more likely to reduce the rate of HIV-1 transmission from mother to baby. Laboratory tests suggest that a higher dose of chlorhexidine will be more effective in killing HIV.
NCT00066950 ↗ Prevention Management Model for Early Childhood Caries (MAYA Project) Completed San Diego State University Phase 3 2003-03-01 The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.
NCT00066950 ↗ Prevention Management Model for Early Childhood Caries (MAYA Project) Completed San Ysidro Health Center Phase 3 2003-03-01 The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.
NCT00066950 ↗ Prevention Management Model for Early Childhood Caries (MAYA Project) Completed University of California, San Diego Phase 3 2003-03-01 The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.
NCT00066950 ↗ Prevention Management Model for Early Childhood Caries (MAYA Project) Completed University of California, San Francisco Phase 3 2003-03-01 The purpose of this study is to determine whether dental disease patterns and transmissable bacteria that are known to cause a severe form of dental decay in young children can be reduced or eliminated by treating mothers and their young infants early on with Chlorhexidine and fluoride varnish applications, respectively as part of a comprehensive Prevention Management Model.
>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 11
Surgery 6
Bacteremia 5
Dental Plaque 4
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Condition MeSH

Condition MeSH for Chlorhexidine Gluconate
Intervention Trials
Infections 25
Infection 25
Communicable Diseases 21
Surgical Wound Infection 15
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Clinical Trial Locations for Chlorhexidine Gluconate

Trials by Country

Trials by Country for Chlorhexidine Gluconate
Location Trials
United States 116
Canada 10
India 6
Turkey 4
Israel 4
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Trials by US State

Trials by US State for Chlorhexidine Gluconate
Location Trials
California 14
New York 8
Texas 8
Montana 8
Michigan 8
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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 51
Phase 3 23
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Chlorhexidine Gluconate
Clinical Trial Phase Trials
Completed 98
Unknown status 18
Recruiting 12
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Clinical Trial Sponsors for Chlorhexidine Gluconate

Sponsor Name

Sponsor Name for Chlorhexidine Gluconate
Sponsor Trials
University of California, San Diego 10
Medline Industries 9
3M 5
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Sponsor Type

Sponsor Type for Chlorhexidine Gluconate
Sponsor Trials
Other 159
Industry 47
U.S. Fed 9
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