A Clinical Trial for Chlorhexidine as Treatment for Vulvovaginal Candidiasis
Status:
Not yet recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
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.
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.