NCT07072273已完成不适用
Open-label Clinical Trial Evaluating an Emollient With Lactobacillus Reuteri for the Treatment of Pediatric Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in SCORing Atopic Dermatitis (SCORAD) after 8 weeks
研究概览
简要总结
The goal of this study is to evaluate the efficacy of the emollient topical formulation containing Lactobacillus reuteri in improving atopic dermatitis symptoms in children.
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
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients of both sexes, aged between 6 months and 12 years, with a confirmed diagnosis of AD based on Hanifin and Rajka criteria (ANNEX VIII).
- •SCORAD index between 20 and 50, inclusive.
- •Signed informed consent by parents or legal guardians.
排除标准
- •History of phototherapy for the treatment of AD.
- •Previous treatment with biologic agents or JAK inhibitors for AD.
- •Use of systemic corticosteroids within one month prior to inclusion in the clinical trial.
- •Use of topical corticosteroids within one month prior to inclusion in the clinical trial.
- •Use of conventional systemic immunosuppressants for AD (e.g., azathioprine, methotrexate, or cyclosporine) within three months prior to inclusion in the clinical trial.
- •Use of oral or topical probiotics within two months prior to inclusion in the clinical trial.
- •Use of topical or systemic antibiotics within one month prior to inclusion in the clinical trial.
- •Known hypersensitivity to the investigational product or any of its components.
- •Underlying immune-mediated diseases requiring systemic corticosteroid therapy.
- •Active infection in areas affected by AD requiring antibiotic, antifungal, or antiviral treatment within the one month prior to inclusion in the clinical trial.
- •Fever at the start of treatment (axillary temperature >37.5 °C or equivalent).
- •Diagnosed immunodeficiency disorders.
- •Current or past diagnosis of malignant neoplasms.
- •Any concurrent dermatologic or medical condition that, in the investigator's opinion, could interfere with the subject's response to treatment or require continuous use of topical corticosteroids.
- •Participation in other clinical research studies involving investigational products within one month prior to inclusion in the clinical trial.
研究组 & 干预措施
Probiotic Ointment
Experimental
Twice-daily application for 8 weeks of an emollient topical formulation containing Lactobacillus reuteri
干预措施: Probiotic Ointment (Other)
结局指标
主要结局
Change in SCORing Atopic Dermatitis (SCORAD) after 8 weeks
时间窗: 8 weeks
Change in SCORing Atopic Dermatitis (SCORAD) index from baseline after 8 weeks of treatment with the topical emollient formulation containing Lactobacillus reuteri
次要结局
- Change in POEM(1, 4 and 8 weeks)
- Change in PIQoL-AD(8 weeks)
- Change in SCORing Atopic Dermatitis (SCORAD) after 1 week(1 week)
- Change in SCORing Atopic Dermatitis (SCORAD) after 4 weeks(4 weeks)
- Change in POEM(1, 4 and 8 weeks)
- Change in PIQoL-AD(8 weeks)
研究者
研究点 (4)
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