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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints:<br /><br><br /><br>The individual concentration of [14C]-radioactivity (recoveries) in all<br /><br>non-biological samples will be established and expressed as percentages<br /><br>relative to the applied dose. For biological samples (blood, faeces and<br /><br>urinary), the individual concentration versus time courses of<br /><br>[14C]-radioactivity will be established and expressed as percentages relative<br /><br>to the applied dose; results will also be expressed as [14C]-TGAeq or as<br /><br>[14C]-TGAeq per unit of mass (g) or volume (mL). </p><br>

Secondary Outcome Measures