Vaginitis is one of the most common gynecological problems in women. Candida albicans is responsible for more than 85% of vaginal fungal infections and reinfection after standard treatment is quite common. The aim of this study is to compare the effects of a zinc-containing vaginal gel and oral fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). The investigator's hypothesis is that zinc-containing vaginal gel may decrease the rate of reinfection after standard treatment with oral 150 mg fluconazole.
Randomized controlled trial will be conducted on 76 women with VVC, as confirmed by clinical and laboratory diagnosis. The participants will be allocated into two groups using blocked randomization method. In the control group participants will receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg) while in the treatment group women will receive a single oral dose of fluconazole (150mg) followed by treatment with a zinc-containing vaginal gel (daily for 2 weeks and twice per week thereafter). Vaginal samples will be collected (vaginal swab and cervicovaginal lavage) at baseline and 4-8-12 weeks after starting treatment. In addition, the clinical signs and symptoms will be assessed before the intervention and follow-ups. Women will be asked to report any new symptoms of vaginal infections and will be asked to return for in-office evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Women receive a single oral dose of fluconazole (150mg) followed by treatment with JUVIA zinc containing vaginal gel (daily for 2 weeks and twice per week thereafter).
Women receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg).
Dr. Secret Private Clinic
Debrecen, HB, Hungary
RECRUITINGClinical cure
The proportion of participants with clinical cure throughout the study period. Clinical cure is defined as follows: complete resolution of signs and symptoms pertaining to VVC and no new sign or symptom of VVC during the follow-up period.
Time frame: 12 weeks
Time to initial symptom resolution.
Time frame: 12 weeks
Vaginal fungal culture for Candida species.
Proportion of negative vaginal fungal culture for Candida species.
Time frame: 12 weeks
Clinical cure at days 28, 56, 84
The proportion of participants with clinical cure at days 28, 56, 84. Clinical cure is defined as follows: complete resolution of signs and symptoms pertaining to VVC and no new sign or symptom of VVC during the follow-up period (at days 28, 56, 84).
Time frame: 12 weeks
Candida severity score
Minimum score: 0; maximum score: 18; higher score worse outcome.
Time frame: 12 weeks
PRA-1 level
Time frame: 12 weeks
CVL zinc level
Time frame: 12 weeks
Vaginal pH
Time frame: 12 weeks
Vaginal neutrophil count
Time frame: 12 weeks
Concentration of calprotectin, IL-1beta, IL-8 in the vaginal sample by ELISA
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 weeks
Vaginal measurement of CEF1, ACT1, PRA1, ECE1, HWP1, SAP6 expression by qRT-PCR
Time frame: 12 weeks
Vulvovaginal symptoms questionnaire
Minimum score: 0; maximum score: 21; higher scores indicates worse symptoms
Time frame: 12 weeks
Vaginal Health Index
Minimum score: 5; maximum score: 25; lower scores indicates worse symptoms
Time frame: 12 weeks
Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 12 weeks