CTRI/2023/03/050690已完成4 期
Dermatological safety evaluation of test products by Primary Irritation Patch Test within 24 hours of apply on healthy human all skin types
Emami Ltd1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年3月16日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of subjects that showed No significant irritation.
研究概览
简要总结
Phase I of the study will involve 24 healthy adult human subjects with Male & Female ratio of 1:1, will be tested for Zandu Stress Relief Balm and Emami Agni Balm.b. Phase II of the study will involve 24 healthy adolescent human subjects with Male & Female ratio of 1:1,will be tested for Zandu Stress Relief balm.
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
- 12.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Phase I; Voluntary men and women ratio of 1:1 between 18 and 65 years.
- •â— Phase II; Voluntary boy and girl ratio of 1:1 between 12 and 17 years.
- •â— Having healthy skin on test area as assessed by dermatological examination.
- •â— For whom the investigator considers that the compliance will be correct.
- •â— Subjects with normal, dry, oily and combination skin.
排除标准
- •Pregnant/nursing mothers.
- •â— Scars, excessive terminal hair, or tattoo on the studied area.
- •â— Dermatological infection/pathology on level of studied area.
- •â— Hypersensitivity, allergy antecedent (to any cosmetic product, raw material) â— Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
结局指标
主要结局
Number of subjects that showed No significant irritation.
时间窗: Baseline, Visit 2,Visit 3, Visit 4, Visit 5
Score of less than or equal to 2 on the Draize scale.
时间窗: Baseline, Visit 2,Visit 3, Visit 4, Visit 5
次要结局
- NA(NA)
研究者
研究点 (1)
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