Dermatological Evaluation of Topical Compatibility, Primary Skin Irritability, Accumulated Skin Irritability, and Dermal Sensitisation

Kley Hertz S/A0 个研究点目标入组 55 人开始时间: 2017年1月最近更新: 2017年1月2日

适应症

试验速览

阶段: 不适用
发起方
入组人数: 55
主要终点: Evaluation of adverse effects in maximized conditions

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Check the safety under normal conditions of use through the verification of emergence signs of irritability and sensitisation of the genital mucosa.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Age between 18 to 70 years old;
•Skin types: I (light caucasian), II (caucasian), III (light dark) and IV (dark)
•intact skin where the product will be applied
•Agreement to comply with the test procedures and attend the clinic in the days and ixed times for medical assessments and application and reading of dressings
•Signature of informed consent form

排除标准

•Pregnancy and lactation
•Use of anti-inflammatory and immunosuppressive drugs from 30 days up to three months prior to selection;
•Diseases that cause immune suppression;
•Personal history of atopy;
•History of sensitisation and irritability to topical products;
•Active cutaneous pathologies (local and / or scattered) that may interfere in the study results;
•Use of new drugs and/or cosmetics during the experiment;
•Skin reactivity;
•Previous participation in a study with the same product under test;
•Volunteers who have congenital or acquired known immunodeficiency;
•Relevant medical history or current evidence of alcohol or other drugs abuse;
•Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
•Sponsor's employees involved in the study, or close family member of an employee involved in the study;

结局指标

主要结局

Evaluation of adverse effects in maximized conditions

时间窗: 60 days

次要结局

未报告次要终点

研究者

发起方

Kley Hertz S/A

申办方类型

Industry

责任方

Sponsor

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