CTRI/2022/11/046975已完成未知
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of sensitive skin type.
ITC Life Sciences Technology Centre0 个研究点目标入组 38 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 38
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
- •1)Subjects with Fitzpatrick skin type III to V
- •2)Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of males and females).
- •3)Subjects scoring greater than 30 for Section 2- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire.
- •4)Subjects identified to have sensitive skin on the basis of Dermatological assessment of skin with fine texture and closeness of blood vessels to the surface.
排除标准
- •1)Subjects who are pregnant or nursing (as confirmed by Urine Pregnancy Test for the determination of Pregnancy).
- •2)Subjects under chronic medication (e.g. Antihistamines, Antifungals, Corticosteroids, topical Steroids, etc.) that might influence the outcome of the study.
- •3)Subjects with cutaneous disease, chronic illness or self-reported Immunological disorders or any other illness including Diabetes, liver disease, HIV or any other serious medical illness.
- •4)Subject suffering from any active clinically significant skin diseases which may contraindicate.
- •5)Subjects with known allergy or sensitization to medical adhesives, bandages or a present condition of allergic response to any cosmetic product.
研究者
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