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临床试验/NCT01167465
NCT01167465撤回4 期

A Clinical Observation to Assess the Safety and Consumers' Satisfaction of Moussik vs Desitin Creamy Ointment in Prophylaxis of Diaper Rash. A Single Blind, Multicenter, Randomized, Cross-over Study

Trima, Israel Pharmaceutical Products0 个研究点开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
4 期
状态
撤回
发起方
主要终点
Six point erythema skin grade

研究概览

简要总结

The purpose of this clinical observation is to evaluate the safety and consumers' satisfaction of Moussik vs Desitin Creamy ointment as a diaper rash protection product.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
3 Months 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female infants aged between 3-18 months who are routine users of disposable diapers

排除标准

  • Children with symptoms of systemic disease or skin lesions.
  • Children diagnosed as having diaper dermatitis at baseline
  • Known hypersensitivity to any of the components of the trial preparations.
  • Children suffering from atopic diseases.
  • Children who have participated during the last month in another clinical trial.

结局指标

主要结局

Six point erythema skin grade

时间窗: After two weeks

0 - Normal skin \+ - Questionable erthema not covering entire area 1. \- Definite erythema 2. \- Erythema and induration 3. \- Vesiculation 4. \- Blister reaction

次要结局

  • Visual analogue scale (VAS) from 0 to 10(After two weeks)

研究者

发起方
Trima, Israel Pharmaceutical Products
申办方类型
Industry
责任方
Sponsor

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