PMOS to evaluate the safety and efficacy of prickly heat baby powder 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
- 25
- 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: To evaluate the safety and efficacy of pricklyheat baby powder in 0-36 months babies
STUDY DESIGN: An open label, post marketing observationalstudy.
Study Methodology:
• Parents/Legally Acceptable Representatives (LARs) of the baby will beprovided with the informed consent document and explained about the study indetail.
• Babies who fulfil the selection criteria will be enrolled into thestudy after written informed consent.
• The subject’s parent /LAR will be provided with The Himalaya pricklyheat baby powder, and they will be instructed on the use the product by thestudy doctor/ coordinator.
• Assessments will be performed on Day 1/baseline and at the end of thestudy visit (Day 15) as per the schedule of events.
• If subjects score for Local intolerance is scored 1= Mild, 2=Moderate,3=Severe, then the undesirable effect page to be completed.
• All undesirable effects to be followed up till the event is stabilizedor 7days whichever is earlier
Study duration: This study is planned for 15 days. The subjectsmust use the test product for all 14 days.
Number of Subjects: 500 subjects will be enrolled.
Study Site: The study will be conducted at Approximately 25sites.
Directions to Use: Sprinkle HimalayaPrickly Heat Baby Powder on to your palms and apply on baby’s skin after bath,nappy changes and before bed-time.
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 general good health as determined from a recent medical history and physical examination.
- •Subjects showing at least 1 or more symptoms of prickly heat such as itching, redness and rashes due to friction (in elbows, arms and knees etc).
- •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 powders 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)