CTRI/2023/07/055838已完成4 期
Clinical Safety, Tolerability, and Suitability and to access clinical prevention of Irritant Diaper Dermatitis (IDD) with Mother Sparsh 99% Pure Water Unscented Baby Wipes on Infant Skin Compared to Cotton Ball Moistened with Clear Water as a Gold Standard for the Prevention of IDD: An Open-label, Comparative , Two-arm, real World Clinical Trial(Phase-IV Study) - Nil
Mother Sparsh Baby Care Pvt Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Healthy male and female infants aged between 1 to 12 months.
- •2. Routine users of baby wipes.
- •3. Subjects mother or legal guardian preferably mother willing to give written informed consent and adhere to all the study procedures.
- •4. Subjects must not participate in any other study during participation in the current study.
排除标准
- •1. Subjects with had limb defects, admitted to the neonatal unit and receiving phototherapy
- •2. Subjects with non-traumatic impairment of epidermal integrity or evidence of skin disorder
- •3. Subjects with a chromosomal abnormality or other syndromic diagnosis
- •4. Subjects with known intolerance to baby wipes or baby wipes ingredients.
- •5. Subjects with psoriasis ichthyosis or a febrile illness.
- •6. Subjects taking any medication likely to influence the skin condition
- •7.Subjects mother or legal guardian preferably mother not willing to give informed consent
研究者
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