An Open-label, Single-arm Interventional Study to Evaluate the Safety and Efficacy of a Probiotic-containing Cream in Children With Dry Skin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- BioGaia AB
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary objective
研究概览
简要总结
The DermaKIDS study is an open-label, single-arm interventional study designed to evaluate the safety and efficacy of a probiotic-containing cream in children with dry skin. Approximately 40 children aged from newborn to 7 years will be enrolled at two study sites in Portugal. Participants will apply the study cream twice daily for a period of four weeks under normal home-use conditions. The primary efficacy endpoint is the change in Overall Dry Skin Score (ODS) from baseline to the end of the study. Safety and efficacy will be assessed through investigator evaluations combined with weekly parent-reported diaries and standardized photographs.
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
- 0 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn - 7 years.
- •ODS ≥ 2 in the target area.
- •Parent/guardian able to comply with weekly diaries/photos and visits.
- •Signed ICF by parent/legal guardian; assent as required.
排除标准
- •Topical medicated treatments on target area within 2 weeks.
- •Active skin infection or severe eczema flare at target site.
- •Known allergy to product components.
- •Participation in another study within 30 days.
- •Any condition judged by investigator to preclude participation.
结局指标
主要结局
Primary objective
时间窗: From Baseline to Week 4
Evaluate change in Overall Dry Skin Score (ODS) from baseline to Week 4 after regular application (twice daily, every day) of Probiotic skin ointment (Study Product) versus baseline.
次要结局
- Secondary objective(From baseline to week 4)