Efficacy and Tolerability of a Probiotic Ointment
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Sofia Nordh, PhD
- 电话号码:+46 (0)8 555 293 00
- 邮箱:son@biogaianewsciences.com
参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
Inclusion Criteria Male and female pediatric patients aged 0.5 years to 15 years with Atopic Dermatitis.
SCORAD Index at D0 = 15 to 50, inclusive. In goodgeneral health as reported by the parent(s)/legal representative(s). Available for the full duration of the study and willing to comply with procedures.
Subjects whose parents or legal representative are willing to sign the informed consent.
Exclusion Criteria Use of phototherapy for atopic dermatitis. Use of systemic corticosteroids within 2 weeks prior to the study. Use of Immunosuppressive or cytostatic drugs within 1 months prior to the study.
Use of antibiotics (topical and systemic) within 15 days prior to the start of the study.
Subjects who are treated with vitamin A-derived compounds or other topical medications for acne in the experimental area during the 30 days prior to the start of the study.
History of sensitivity to the study products, or its components. History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
Subjects with active infection in atopic dermatitis areas requiring antibiotics, antifungals, or antiviral agents within 7 days before baseline participation in any study that would interfere with the current study.
Fever (temperature> 37.5 °C axillary or equivalent) during 48 hours prior the start of the study.
Pathologies associated with immunodeficiency or cancer processes. Any concurrent dermatologic or medical conditions that may interfere with the investigators ability to assess the subject's response to the study drug or require the continued use of topical corticosteroids.
Subjects who have received the schedule MMR vaccination during the study period or have received the last dose within three weeks prior the start of the study.
Subjects who participates in any study that would interfere with the current study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Probiotic Ointment
Probiotic Ointment 2x day
|
Probiotic ointment
|
|
实验性的:Comparator Product
Comparator product 2x day
|
Basic lotion
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary Endpoint
大体时间:28 days
|
To evaluate the change in SCORAD from baseline to Day 28.
|
28 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Secondary Endpoint
大体时间:14 days
|
To evaluate the change in SCORAD from baseline to Day 14
|
14 days
|
|
Secondary Endpoint
大体时间:14 and 28 days
|
To evaluate the change in local SCORAD from baseline to Day 14 and Day 28
|
14 and 28 days
|
|
Secondary Endpoint
大体时间:14 and 28 days
|
To evaluate the change in skin barrier function (TEWL) from baseline to Day 14 and Day 28
|
14 and 28 days
|
|
Secondary Endpoint
大体时间:14 and 28 days
|
To evaluate the change in POEM score from baseline to Day 14 and Day 28
|
14 and 28 days
|
|
Secondary endpoint
大体时间:14 and 28 days
|
To evaluate the change in itch NRS from baseline to Day 14 and Day 28
|
14 and 28 days
|
|
Secondary Endpoint
大体时间:28 days
|
To evaluate the use of topical corticosteroids during the study period
|
28 days
|
|
Secondary Endpoint
大体时间:28 Days
|
To explore changes in skin microbiota between baseline and Day 28
|
28 Days
|
|
Secondary Endpoint
大体时间:28 days
|
To evaluate patient-reported tolerability and reported adverse events during the study period
|
28 days
|
合作者和调查者
赞助
合作者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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