KCT0005895招募中未知
A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of KBL693 on atopic dermatitis in children
Kobiolabs0 个研究点目标入组 159 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 159
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 2(Year) 至 16(Year)（—）
- 性别
- All
入选标准
- •1) A person who agrees to participate in this clinical trial and has voluntarily signed a Informed consent form with his/her
- •parents (or legal representative).
- •2) A person who are over 2 years of age and under 16 years of age.
- •3) A person who have intermittent or persistent atopic dermatitis symptoms for more than six months
- •4) A person whose SCORAD score is 25 to 50 points (mild-modelate) in Visit 1 and 2.
- •5) A person diagnosed with atopic dermatitis according to the diagnosis criteria of Hanifin and Rajka.
排除标准
- •1) A person who has severe skin diseases and systemic diseases other than atopic dermatitis.
- •2) A person who has administered systemic antibiotics, systemic corticosteroids, and antihistamines in relation to atopic
- •dermatitis within four weeks of the start of the clinical trial.
- •3) A person who administers systemic immunosuppressants within 12 weeks of the clinical trial.
- •4) A person who administers medicine, herbal medicine, and health functional foods to improve atopic dermatitis within one
- •week of the start of the clinical trial.
- •5) A person who has taken probiotics health functional foods, consistently fermented milk, and digestive (at least four times
- •a week) within one week of the start of the clinical trial.
- •6) A person who has received phototherapy within four weeks of the start of the clinical trial.
- •7) A person who has plans to participate in other clinical trials during clinical trial(excluding observational research).
- •8) A person who participated in other clinical trials within four weeks of the start of the clinical trial(excluding observational
- •9) A person who is deemed unfit for the clinical trial by investigator.
- •10) A person who has an anamnesis of hypersensitivity to probiotics and pseudo-sequences.
研究者
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