Estudio Piloto Sobre la Efectividad de la acción Conjunta de Una Crema Corporal y un bálsamo Corporal en niños Con Dermatitis atópica
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 4
- 主要终点
- Changes in Atopic Dermatitis severity according SCORAD test
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a combined dermatological treatment in children up to 5 years old with mild or moderated atopic dermatitis.
详细描述
The intensive cream and body lotion of the PediATOPIC® products are two emollients expressly formulated to serve as adjuvants in the management of Atopic Dermatitis. Both products contain Dermosense complex®, a complex that includes 3 products: Bodyfensine peptide® (inductor of dephensine synthesis against microbial aggressions), Unimoist® (the mimetizing complex of the skin's natural hydration factor), and Ramnosoft® (polysaccharide that inhibits the adhesion of pro-inflammatory drugs and bacteria, while limiting the spread of inflammatory reactions in skin cells). They also contain Bisabolol, (plant extract with anti-inflammatory, anti-irritant and antimicrobial properties) and Panthenol (Pro vitamin B5 that accelerates the skin's natural regeneration process).
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
- 1 Month 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 1 month to 5 years old
- •Patients with atopic dermatitis mild-moderate with an SCORAD=16-40
排除标准
- •Other dermatological diseases that could interfere with the study results
- •Corticoids use during 3 weeks prior to the study
- •Antibiotics use to treat atopic dermatitis during 3 weeks prior to the study
- •Use of topical immunomodulators
- •Concurrent use of other emollients
研究组 & 干预措施
Combined dermatological treatment
A combined treatment of two emollient products will be applied:
- Pediatopic treatment cream during acute stages of atopic dermatitis and
- Pediatopic body lotion during stable stages
干预措施: Pediatopic Treatment Cream (Other)
Combined dermatological treatment
A combined treatment of two emollient products will be applied:
- Pediatopic treatment cream during acute stages of atopic dermatitis and
- Pediatopic body lotion during stable stages
干预措施: Pediatopic Body lotion (Other)
结局指标
主要结局
Changes in Atopic Dermatitis severity according SCORAD test
时间窗: At 15 days
\<16 mild; \>16\<40 moderate; \>40 severe
次要结局
- Number of atopic dermatitis outbreaks(At 5 months)
- Duration of stable periods (between outbreaks)(At 5 months)
- Patient satisfaction assessed by Visual Analog Scales(At 5 months)
- Treatment compliance assessed by Morisky-Green test(At 5 months)