Consumer exposure to a depilatory product. A [14C]-TGA mass balance study. - [14C]-TGA Depilatory

'Oréal Worldwide Safety Evaluation0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•Female; Age 18-45 years;
•Healthy as assessed by health questionnaire, physical examination and clinical chemistry (fasting state)
•Willing to refrain from blood donation during the whole study
•Willing to use adequate measures to avoid pregnancy during the whole study
•Willing to accept use of all anonymous data, including publication, and the confidential use and storage of all data
•Willing to refrain from hair removal (2 weeks) prior to day 01 of the study, either by mechanical or chemical means
•Avoiding using soap or products containing alcohol 24 hours before and after day 01 of the study.
•Avoiding prolonged sun exposure before and after the study.

•Participation in any clinical trial including blood sampling and/or adminis¬tration of substances up to 90 days before Day 01 of this study
•Participation in any clinical trial or medical treatment including administration of a radiolabelled test substance up to 1 year before Day 01 of this study
•Having a history of metabolic or endocrine diseases
•Positive pregnancy test (urine)
•Prescribed medication (except oral contraceptives and paracetamol)
•Alcohol consumption more than 14 units/week (females) (1 unit of alcohol equals 10 grams of ethanol)
•Recent blood donation (<1 month prior to Day 01 of the study)
•Having a history of medical or surgical events that may significantly affect the study outcome including dermatological diseases such as having dermatitis or particular skin diseases
•Irritated skin, scars, cuts, wounds, dermal abnormalities or sun burns on the study areas
•Not having a general practitioner and/or not willing to accept information-transfer concerning participation in the study, or information regarding her/his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from her general practitioner
•Having a positive response (irritation, tingling, itching, etc) to the pre-test conducted on a small area on the volar forearm before Day 01 of the study.

发起方

'Oréal Worldwide Safety Evaluation