PMOS to evaluate the safety and efficacy of gentle baby wipes_extra large wipes in 0-36 months babies
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 24
- 主要终点
- To evaluate the safety and efficacy of Test Product in study population.
研究概览
简要总结
STUDY OBJECTIVE: Toevaluate the safety and efficacy of gentle baby wipes in 0-36 months babies
STUDYDESIGN: An open label, post marketing observational study.
Study Methodology:
• Parents/LegallyAcceptable Representatives (LARs) of the baby will be provided with theinformed consent document and explained about the study in detail.
• Babies who fulfilthe selection criteria will be enrolled into the study after written informedconsent.
• The subject’sparent /LAR will be provided with The Himalaya gentle baby wipes/extra-largewipes, and they will be instructed on the use the product by the study doctor/coordinator.
• Assessments willbe performed on Day 1/baseline and at the end of the study visit (Day 15) asper the schedule of events.
• If subjects scorefor Local intolerance is scored 1= Mild, 2=Moderate, 3=Severe, then theundesirable effect page to be completed.
• All undesirableeffects to be followed up till the event is stabilized or 7days whichever isearlier
Study duration: Thisstudy is planned for 15 days. The subjects must use the test product for all 14days.
Number of Subjects:500 subjects will be enrolled.
Study Site: The studywill be conducted at Approximately 25 sites.
Directions to Use: Pull out Wipes andgently clean the baby, carefully reseal the pack flap to keep wipes fresh andmoist for the future (Use 1 extra-large baby wipes to clean whole body).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 36.00 Month(s)（—）
- 性别
- All
入选标准
- •Subjects in the age group of 0 to 36 months -inclusive of both genders
- •Subjects in general good health as determined from a recent medical history and physical examination
- •Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to comply with the study protocol.
排除标准
- •A known history or present allergic condition that may require medical attention
- •Chronic illness which may influence the cutaneous assessment
- •Subjects not willing to stop the use of other wipes during study period.
结局指标
主要结局
To evaluate the safety and efficacy of Test Product in study population.
时间窗: Study duration: This study is planned for 15 days.
次要结局
- Not Applicable(Not Applicable)