CTRI/2022/09/045339已完成不适用
EVALUATION OF IRRITATION POTENTIAL OF PAIN BALMS (A & B) FROM AMRUTANJAN R&D DEPT. THROUGH DERMATOLOGICAL EVALUATION BY SINGLE OCCLUSIVE PATCH TEST ON HEALTHY ADULT HUMAN VOLUNTEERS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- the severity mean scores for Erythema/dryness/wrinkles will be calculated and mean score of oedema will be calculated separately
研究概览
简要总结
The subjects selected for this study will be healthy females and males, aged between 18 and55 years old. In which 12 will be females and 12 will be male subjects.selection of the subjects were carried out as per the norms indicated in the protocol. Theentire study procedure,patch application, patch reading and grading is detailed intheprotocol and followed as per the protocol. The Patch applied contain Finn’s chamber. The patch is applied on the back or shoulder area of the subjects and will be in contact with the skin for 24 hours
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy subjects with healthy skin on the studied anatomic unit (free of eczema, wounds & any other inflammatory scar) 2.Age group of 18 to 55 years, 12 male and 12 female subjects.
- •3.Compliance with the study procedures involved.
排除标准
- •1.Pregnant and lactating women 2.Subjects with any other skin disorders.
- •3.Use of any other topical agents for any skin related conditions (at the site of application of patch) during the past 30 days.
结局指标
主要结局
the severity mean scores for Erythema/dryness/wrinkles will be calculated and mean score of oedema will be calculated separately
时间窗: Day 1, 2 and 8
次要结局
- Combined mean score calculation(Day 8)
研究者
研究点 (1)
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