Randomized controlled trial to assess the effectiveness of a zinc-containing vaginal gel and fluconazole on treatment and recurrence of vulvovaginal candidiasis.

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 was to compare the effects of a zinc-containing vaginal gel and oral fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). Our hypothesis is that zinc-containing vaginal gel may decrease the rate of reinfection after standard treatment with oral 150 mg fluconazole.

Our 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.

Efficacy measurements will include collection of clinical signs (erythema, edema, excoriation) and symptoms (itching, burning, irritation) of vulvovaginitis using a scoring scale of 0–3 (0 = none, 1 = mild, 2 = moderate, 3 = severe) for each sign or symptom to give a total severity score of 0–18 [Sober et al]. In addition, a KOH wet mount test, vaginal fungal culture and cervicovaginal lavage (CVL) will be performed at each visit.

Primary outcome: The proportion of participants with clinical cure throughout the study period. Clinical cure was 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.