CTRI/2018/05/013752已完成不适用
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types
ITC Life Sciences Technology Centre1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2018年5月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Evaluate dermatological safety
研究概览
简要总结
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. 20 test products will be tested against 01 control with 24 subjects. total study duration is 10 days.
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
- •Healthy male and female subjects in the age group of
- •55 years (both the ages inclusive). 2)Subjects with Fitzpatrick skin type III to V. 3)Subjects willing to give a voluntary written informed consent. 4)Subjects willing to maintain the patch test in position for 24 hours. 5)Subject having not participated in a similar investigation in the past two weeks. 6)Subjects willing to come for regular follow up visits. 7)Subjects ready to follow instructions during the study period. 8)Subjects without any open wounds, cuts, abrasions, irritation symptoms.
排除标准
- •Subjects with Infection/ allergy/ irritation symptoms on the upper back area identified for patch application.
- •Subjects with any kind of skin allergy, antecedents or atopy or cutaneous disease which may influence the study results.
- •Athletes and subjects with history of excessive sweating.
- •Subjects on oral corticosteroid.
- •Subjects participating in any other cosmetic or therapeutic trial.
- •Subjects with any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.
结局指标
主要结局
Evaluate dermatological safety
时间窗: Visit 01, 02, 03, 04 and 05
次要结局
- Not applicable(Not applicable)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Dermatological Assessment of Primary Dermal Irritability Accumulated, Sensitization, Photoallergy and Phototoxicity.Sensitivity, ContactNCT04332445Herbarium Laboratorio Botanico Ltda55
已完成
不适用
Dermatological Assessment of Primary Dermal Irritability Accumulated and SensitizationSensitivity, ContactNCT04248556Herbarium Laboratorio Botanico Ltda69
已完成
不适用
Safety assessment of test products on skin.CTRI/2022/04/041901ITC LIMITED ITC Life Sciences and Technology Centre23
已完成
Unknown
Checking of safety of productsCTRI/2024/04/065604ITC LIMITED24
尚未招募
Unknown
Safety check of products on human volunteersCTRI/2024/07/070779ITC LIMITED