CTRI/2011/09/002025已完成2 期
To Assess The Efficacy and Safety Of Enhanced Virgin Coconut Oil Cream in Tinea Versicolor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- dermatological
研究概览
简要总结
A mono-centered, single arm, open label study to evaluate the efficacy and safety of IP in reducing the itchiness associated with Tinea versicolor infection in adult subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and/or female subjects who have been diagnosed with tinea Versicolor.
- •Subjects over 19 years of age.
- •Subjects with moderate to severe grade tinea versicolor.
- •Subjects who have not used any topical antifungal products to the affected area in the past 30 days and topical steroid in the past 14 days.
- •Subjects willing to give a written informed consent and come for regular follow up.
排除标准
- •Use of topical antifungal to the affected area in past 30 days 2) Use of topical steroid to the affected area in the past 14 days 3) Pregnant and breast feeding women 4) Patient with dermatological condition that may interfere with the study result.
结局指标
主要结局
dermatological
时间窗: Screening | visit, | Baseline, Week 1, Week 2, Week 4
evaluation, subject self assessment, Photography whereas Mycological assessment will be
时间窗: Screening | visit, | Baseline, Week 1, Week 2, Week 4
done on Screening, Week 2 and Week 4 visit.
时间窗: Screening | visit, | Baseline, Week 1, Week 2, Week 4
次要结局
未报告次要终点
研究者
研究点 (1)
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