A Clinical Trial for Chlorhexidine as Treatment for Vulvovaginal Candidiasis

NCT05059145 | Unknown Phase 2

• 1 other identifier: Chlorhex-KKDS-2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. The 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.

Conditions

Candidiasis, Vulvovaginal

Keywords

Recurrent vulvovaginal candidiasis

Outcome Measures

Primary Outcomes (1)

• Proportion of women in each group that has cleared the vulvovaginal infection

  Negative vaginal culture for Candida albicans

  Up to 10 days

Secondary Outcomes (6)

• Prophylactic effect

  6 months

• Adverse events

  6 months

• Symptom score

  6 months

• Examination score

  6 months

• Vaginal lactobacillus content

  6 months

Study Arms (2)

Chlorhexidine gluconate, 1% vaginal cream

EXPERIMENTAL

8 ml vaginal cream every night for a week and then prophylactic treatment with 8 ml/week for another 11 weeks

Drug: Chlorhexidine Gluconate

Fluconazole, 150 mg oral capsule

ACTIVE COMPARATOR

Fluconazole150 mg (oral capsule) every 3 days for the first 3 doses, then prophylactic treatment with 150 mg/week for another 11 weeks

Drug: Fluconazole

Interventions

Chlorhexidine Gluconate DRUG

Vaginal cream 1%

Also known as: Hibitane vaginal cream

Chlorhexidine gluconate, 1% vaginal cream

Fluconazole DRUG

150 mg oral capsule

Fluconazole, 150 mg oral capsule

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• A history of \> 2 candida infections the last year
• Symptoms of acute vulvovaginal candida infection
• Culture verified infection with Candida albicans
• Adequate contraceptive method
• Able to understand oral and written information in Swedish
• The subject has given written consent to participate in the study

You may not qualify if:

• Severe somatic or mental illness (including liver and kidney failure and cardiac disease)
• Immunosuppressive medication
• Pregnancy
• Lactation
• Other ongoing gynecological infections
• Allergy to fluconazole or chlorhexidine gluconate
• Citalopram or other medication that might have impact on the QT interval (terfenadin, cisaprid, astemizol, pimozid, kinidin, erythromycin, halofantrin, amiodaron)
• Participation or recent participation (30 days) in a clinical study with an investigational product. Previous participation in this study.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Danderyd Hospital, Dep. of Obstetrics and Gynecology

Stockholm, 182 88, Sweden

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

chlorhexidine gluconate; Fluconazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Cathrin Alvendal, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Bohm-Starke, MD, PhD

CONTACT

+46812355000; nina.bohm-starke@sll.se

Helen Fagraeus, Midwife

CONTACT

+46812355000; helen.fagraeus@sll.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: September 28, 2021
• Study Start: April 27, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)