KCT0005646招募中未知
A 12 week, RAndomized, Double-blind, Placebo-controlled clinical trial for the evaluation of the efficacy and safety of BRB&PG-F on atopic dermatitis in chidlren
Ajou University Hospital0 个研究点目标入组 100 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
- 100
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
- 3(Year) 至 15(Year)（—）
- 性别
- All
入选标准
- •1) Those who agreed to participate in this trial and presented a document, voluntarily signed by the subject and the parent (or legal representative)
- •2) Those who aged 3 to 15 years
- •3) Those who have persistent atopic dermatitis symptoms for more than 6 months
- •4) Those who have SCORAD scores between 25 and 50 (moderate) at the time of screening and randomization
排除标准
- •1) Those who have skin disease other than atopic dermatitis, which impairs accurate evaluation of atopic dermatitis results such as irritant contact dermatitis, allergic contact dermatitis, infection (e.g., ohms) or psoriasis
- •2) Those who have skin or dermatitis (bacteria, viruses, fungi) that require full body treatment within 2 weeks of screening (except for localized water lions with fewer than 20 lesions and viral warts)
- •3) Those who have systemic diseases such as immune deficiencies, autoimmune diseases, cancer, etc.
- •4) Those who administered the following medicines or received the following treatment before screening
- •A. Those who administered systemic antibiotics, corticosteroids and immunosuppressants within 2 weeks of screening
- •B. Those who took herbal medicine, health function foods in relation to atopic dermatitis within 4 weeks of screening are {Demonne products (VSL#3) and lactobacillus products licensed for atopic dermatitis (Sake Probio65, Lactobacillus plantarum CJLP133, L. Rhamnosus IDCC3201)}
- •C. Those who received phototherapy within 4 weeks of screening
- •D. Those who administered local steroids, antihistamines, local immuno-suppressants, oral antihistamines or local antibiotics within a week of screening
- •5) Those who have infectious bowel disease history within 2 weeks of screening
- •6) Those who have an overreaction history in the ingredients of food for human application testing (e.g. mushrooms, balloon flower root, black rice and milk)
- •7) Those who participated in other clinical trials within 2 months of the start of this clinical trial (including a human application test) or have a plan to participate in another interventional clinical trial (including a human application trial) after the start of this human application trial
- •8) Those who considered as inappropriate for this clinical trial by the judgment of the investigator
研究者
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