PMOS to evaluate the safety and efficacy of nourishing baby soap 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: Toevaluate the safety and efficacy of nourishing baby soap in 0-36 months babies
Study Design: Anopen label, post marketing observational study.
Study Methodology:
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Parents/LegallyAcceptable Representatives (LARs) of the baby will be provided with theinformed consent document and explained about the study in detail.
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Babies whofulfil the selection criteria will be enrolled into the study after writteninformed consent.
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The subject’sparent /LAR will be provided with The Himalaya Nourishing Baby Soap, and theywill be instructed on the use the product by the study doctor/ coordinator.
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Assessments willbe performed on Day 1/baseline and at the end of the study visit (Day 15) asper the schedule of events.
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If subjectsscore for Local intolerance is scored 1= Mild, 2=Moderate, 3=Severe, then theundesirable effect page to be completed.
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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: Wet the baby’s body andface with water, apply the soap generously, work up lather and rinse withwater.
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
- Female
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 soaps 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. | Timepoints: Baseline and 2 weeks.
Primary outcome:
时间窗: Study duration: This study is planned for 15 days. | Timepoints: Baseline and 2 weeks.
1. Subjective assessment for tangle free and soft & shiny hair
时间窗: Study duration: This study is planned for 15 days. | Timepoints: Baseline and 2 weeks.
2. Dermatology assessment for mildness and gentleness of baby’s skin.
时间窗: Study duration: This study is planned for 15 days. | Timepoints: Baseline and 2 weeks.
次要结局
- Not Applicable(Not Applicable)