A Modified Draize Repeat Insult Patch Test in a Shared Panel of 100 Healthy Volunteers to Investigate the Irritation and Sensitization Potential of 1 Test Article Following Repeated Cutaneous Patch Applications

Amazentis SA1 个研究点分布在 1 个国家目标入组 112 人开始时间: 2026年4月20日最近更新: 2026年6月17日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Amazentis SA
入组人数: 112
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to investigate the irritation and sensitization potential of 1 topically applied test article containing Mitopure in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy males or females,18 years of age or older (50% with sensitive skin).
•Completed written informed consent.
•Female subject agrees to use an acceptable method of birth control (e.g. abstinence, condoms, hormonal birth control, IUD, tubal ligation, hysterectomy, bilateral oophorectomy, hysterectomy, post-menopausal for at least one year or male partner vasectomy).

排除标准

•Pregnancy or lactation.
•Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
•Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.

研究者

发起方

Amazentis SA

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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