CTRI/2010/091/001309已完成未知
Evaluation of dermatological safety of Odomos Oil with a 48 hours closed patch skin sensitization test on healthy children - NI
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria:
- •?Healthy children volunteers
- •?Legally acceptable representatives ready to sign the informed consent
- •?Subjects willing to maintain the applied patch in position for 48 hours
- •?Subjects of age group 2 - 12 years
- •?Subject has not participated in a similar investigation in the past four weeks.
- •?All willing parents and subjects will sign voluntarily in the parent informed consent and assent document and come for regular follow up.
- •?Subjects ready to follow instructions during the study period.
排除标准
- •Exclusion Criteria
- •?Infection, allergy on the tested area
- •?Skin allergy antecedents or atopic subjects
- •?Hyper sensitivity to any component of the tested products
- •?Athletes and subjects with history of excessive sweating
- •?Cutaneous disease which may influence the study result
- •?Chronic illness which may influence the cutaneous state.
- •?Subjects on oral corticosteroid with dose >10mg/day
- •?Subject in an exclusion period or participating in any other cosmetic or therapeutic trial.
- •?Any underlying medical illness including diabetes, liver disease, HIV, or any other serious medical illness.
研究者
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