NCT07701447尚未招募不适用
Efficacy and Tolerability of a Probiotic Ointment
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- BioGaia AB
- 入组人数
- 92
- 主要终点
- Primary Endpoint
研究概览
简要总结
This study evaluates the tolerability and efficacy of a probiotic ointment compared with a comparator lotion in children with atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Probiotic Ointment
Experimental
Probiotic Ointment 2x day
干预措施: Probiotic Ointment (Other)
Comparator Product
Experimental
Comparator product 2x day
干预措施: Comparator product (Other)
结局指标
主要结局
Primary Endpoint
时间窗: 28 days
To evaluate the change in SCORAD from baseline to Day 28.
次要结局
- Secondary Endpoint(14 and 28 days)
- Secondary endpoint(14 and 28 days)
- Secondary Endpoint(28 days)
- Secondary Endpoint(14 days)
- Secondary Endpoint(28 Days)
研究者
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