CTRI/2024/11/077114已完成不适用
Evaluation of Dermatological Safety of an Investigational Urea Nano-Emulsion Product Through a 24-Hour Occlusive Patch Test on Healthy Human Subjects.
CROM Clinical Research and Medical Tourism Pvt. Ltd. Division Nano Agro Technologies1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月23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
- 60
- 试验地点
- 1
- 主要终点
- Safety on dermal patch tests for all the products
研究概览
简要总结
Total number of subjects: 60 healthy human subjects
Gender: Male and Female
Age group: 18-60 years
Test site: At the nape of the neck, in between two shoulder blades in males.
Forearm in women
Test period: 9 days for all subjects including screening and enrollment period.
Patch test unit: Derma proof Aluminium Finn chamber prefixed to a scanpore tap
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Male
入选标准
- •Subjects in age group
- •55 years (both the ages inclusive). Healthy male subjects. Subjects with Fitzpatrick skin type III to V. Subjects willing to give a written informed consent. Subjects willing to maintain the patch test in position for 24 hours. Subject having not participated in a similar investigation in the past one month. Subjects willing to come for regular follow up visits. Subjects ready to follow instructions during the study period.
排除标准
- •Infection, allergy on the tested area.
- •Skin allergy, antecedents or atopic subjects.
- •Athletes and subjects with history of excessive sweating.
- •Cutaneous disease which may influence the study result.
- •Subjects on oral corticosteroid .
- •Subjects participating in any other cosmetic or therapeutic study.
- •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
Safety on dermal patch tests for all the products
时间窗: 0 hrs, 24 hrs and and 7 days
次要结局
未报告次要终点
研究者
Dr Vijaykumar Patil
Prakash Institute of Medical Science and Research
研究点 (1)
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