Effectiveness and Safety of Daktacort Feminine Care Cream in the Treatment of Vulvar Candidiasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Mean Time to Itch Relief
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in the treatment of participants with vulvar candidiasis (yeast infection of the vulva).
详细描述
This is an open label (all people know the identity of the intervention), single-arm, prospective (study following participants forward in time) study to evaluate the efficacy and safety of miconazole plus hydrocortisone cream in participants with vulvar candidiasis. Participants will be evaluated and assessed on the degree of pruritus (itchiness) and screened for candidiasis on the baseline. Participants will apply the cream once enrolled and will be assessed for 1-hour to get the time to relief. Each participant will apply the study medication topically (applied to skin) to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the vulvar area affected and the treatment should be continued without interruption. Participants will be followed-up after 14 days and will be assessed clinically for signs and symptoms of vulvar candidiasis; if not cured, participants will continue the medication up to Day 28. Primary efficacy endpoint will be the time needed to achieve pruritus relief. Participants' safety will be monitored throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Positive potassium hydroxide (KOH) mount / Gram stain (a method used to diagnose bacterial infection) of vulvar (the tissues around the opening to the vagina) scrapings - Vulvar candidiasis with at least mild pruritus
排除标准
- •Participants with vaginal candidiasis (yeast infection of the vagina) - History of allergy to miconazone (an antifungal agent, is used for skin infections such as vaginal yeast infections) and/or other components of the study drug - Pruritus caused by etiologic (the cause) agents aside from fungi - Tuberculous (bacterial infection that usually results in a serious lung disorder) skin infection - Herpes simplex (viral infection), vaccinia (vaccine used to eradicate smallpox), all forms of varicella (infection caused by the varicella-zoster virus), and vulvar malignancy (cancer)
研究组 & 干预措施
Miconazole plus Hydrocortisone
干预措施: Miconazole plus Hydrocortisone (Drug)
结局指标
主要结局
Mean Time to Itch Relief
时间窗: 1-hour after initial application
Time to itch relief is defined as time needed to achieve pruritus (itchiness) relief.
次要结局
- Percentage of Participants Who Achieved Clinical Cure(Baseline up to Day 28)
- Modified Itch Severity Scale (MISS) Score(Baseline and Day 28)
- Pruritus Symptom Assessment by Visual Analog Scale (VAS) Score(1-hour after initial application)