NCT05918237已完成不适用
Pilot Study to Test the Effects of Arctiva on Mild to Moderate Eczema
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Severity Scoring of Atopic Dermatitis Index (SCORAD) improvement [Timeframe : Baseline to Day 28]
研究概览
简要总结
Up to 30 participants with mild to moderate atopic dermatitis/eczema will be enrolled to apply study Investigational Product for 4 weeks.
详细描述
This will be a 4-week single arm study. This study will be executed by one clinical research company in one research center accruing 30 subjects with mild to moderate Eczema/atopic dermatitis. Patients ages 18-75, will be enrolled. Subjects that are enrolled will be placed on Locus's Over The Counter cream "Arctiva" twice per day for 4 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female;18-75 years of age
- •Have a clinical diagnosis of Mild to Moderate Eczema or Atopic Dermatitis
- •Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation prior to the start of any screening procedure
排除标准
- •Patients using topical corticosteroids steroidal creams and other agents within 7 days prior to first dose of trial Eczema treatment.
- •Use of systemic corticosteroids or other agents for atopic dermatitis within 4 weeks prior to first dose of trial treatment.
- •Active bacterial, viral, or fungal skin infections
结局指标
主要结局
Severity Scoring of Atopic Dermatitis Index (SCORAD) improvement [Timeframe : Baseline to Day 28]
时间窗: 28 Days
Change from Baseline to Day 28 in overall Severity Scoring of Atopic Dermatitis Index (SCORAD)
次要结局
- Change from Baseline in Dermatology Life Quality Index (DLQI) [Timeframe: Baseline to Day 28](28 Days)
- Change from baseline in Patient-Oriented Eczema Measure (POEM). [ Time Frame: Baseline and 28 Days](28 Days)
研究者
研究点 (2)
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