Randomized Controlled Trial to Assess the Effectiveness of a Zinc-containing Vaginal Gel and Fluconazole on Treatment and Recurrence of Vulvovaginal Candidiasis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Clinical cure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, nonpregnant female participants aged ≥18 years with a clinical diagnosis of symptomatic acute VVC.
- •Positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae/pseudohyphae or budding yeast cells.
- •Presence of ≥1 vulvovaginal sign.
- •Presence of ≥1 vulvovaginal symptom.
- •Composite Candida severity score of ≥4.
排除标准
- •Abnormal Papanicolaou smear in the preceding 12 months.
- •Patients who had oral or intravenous antifungal agents within 4 weeks, or used topical vaginal antifungal drugs within 1 week before the study.
- •Known human immunodeficiency virus infection,
- •Liver disease or abnormal liver function tests, lactation, pregnancy, and allergy to azole agents or zinc.
- •Women with non-albicans Candida species will be excluded from the final data analysis.
研究组 & 干预措施
JUVIA zinc-containing vaginal gel and Fluconazole
JUVIA zinc containing vaginal gel group. Receive oral fluconazole treatment (150 mg) and after that participants will use a zinc containing- vaginal gel for 12 weeks.
干预措施: JUVIA zinc containing vaginal gel treatment (Drug)
JUVIA zinc-containing vaginal gel and Fluconazole
JUVIA zinc containing vaginal gel group. Receive oral fluconazole treatment (150 mg) and after that participants will use a zinc containing- vaginal gel for 12 weeks.
干预措施: Fluconazole 150Mg Tab (Drug)
Fluconazole
Control group. Receive oral fluconazole treatment.
干预措施: Fluconazole 150Mg Tab (Drug)
结局指标
主要结局
Clinical cure
时间窗: 12 weeks
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.
次要结局
- Vaginal fungal culture for Candida species.(12 weeks)
- Clinical cure at days 28, 56, 84(12 weeks)
- CVL zinc level(12 weeks)
- Time to initial symptom resolution.(12 weeks)
- Candida severity score(12 weeks)
- PRA-1 level(12 weeks)
- Vaginal pH(12 weeks)
- Vaginal neutrophil count(12 weeks)
- Concentration of calprotectin, IL-1beta, IL-8 in the vaginal sample by ELISA(12 weeks)
- Vaginal measurement of CEF1, ACT1, PRA1, ECE1, HWP1, SAP6 expression by qRT-PCR(12 weeks)
- Vaginal Health Index(12 weeks)
- Reported Adverse Events (AEs) and Serious Adverse Events (SAEs)(12 weeks)
- Vulvovaginal symptoms questionnaire(12 weeks)