CTRI/2018/08/015474已完成未知
To evaluate the in-vivo safety of investigational product by repeat use test (14 days) in healthy female subjects of varied eye conditions (Normal Condition & Contact Lens Users) and varied skin conditions (Normal, Oily, Dry and Sensitive).
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- ITC Limited
- 入组人数
- 37
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
- •Standard criteria
- •1.Indian Female subjects
- •2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup)
- •3.Between 18 and 40 years of age.
- •4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scarââ?¬Â¦.)
- •Specific criteria
- •1.Subjects representing varied skin types (ideally equal representation of all 5 skin types ââ?¬â?? Oily, Normal, Dry, Combination & Sensitive [Sensitive skin type : As per the Baumannââ?¬•s questionnaire answered by subjects, please refere appendix 7])
- •2.Subjects representing varied eye conditions (ideally equal representation of Normal Condition and Contact Lens Users).
- •3.Having a habit of applying make up and waterproof make up.
排除标准
- •Exclusion Criteria
- •Standard criteria
- •1.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
- •2.Having refused to give her assent by not signing the consent form
- •3.Taking part in another study liable to interfere with this study
- •4.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months)
- •5.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products or food products or to latex
- •6.Having a progressive asthma (either under treatment or last fit in the last 2 years)
- •7.Being epileptic
- •8.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months)
- •9.Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •10.Having cutaneous hypersensitivity.
- •11.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •12.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •13.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit
- •14.Having applied a cosmetic product (included make-up) on the studied areas the first day of the study.
- •15.Refusing to follow the study restrictions
- •16.Specific criteria
- •17.Having ocular problems (stye, chalazion, conjunctivitis).
- •18.Having known history or present condition of allergic response to any cosmetic products (eye/ facial cosmetic products).
- •19.Having eye infection or allergy.
- •20.Having extremely sensitive eye condition.
- •21.Having any form cutaneous disease which may influence the study result.
研究者
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