geen not applicable
Conditions
Interventions
Two days prior to the start of the study, volunteers will come to TNO for the
sensibility test (allergy) for the hair dye. The study will last for 1 day
(24h) and two mornings. On the first study da
Sponsors
The Procter & Gamble Company
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Apparently healthy as assessed by the TNO Health and lifestyle questionnaire, limited Physical examination and results of the pre-study laboratory tests 2. Age [>= 18 and
Exclusion criteria
Exclusion criteria: 1. Participation in any clinical trial or medical treatment including administration of a radio labelled test substance up to 1 year before Day 01 of this study 2. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study 3. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances 4. Having a history of medical or surgical events that may significantly affect the study outcome, including metabolic or endocrine diseases, or dermatological diseases such as having dermatitis or particular skin diseases 5. A past history of having had a temporary henna tattoo applied or currently having a temporary henna tattoo 6. Prescribed medication (oral contraceptives and paracetamol excluded) 7. Bald headed or balding 8. Scars, cuts, wounds or dermal abnormalities on the scalp 9. Having a known allergy to hair colourants 10. Having a positive response to the allergy alert test to the test formulation (higher concentration), conducted 2 days in advance of Day 01 of the study 11. Positive pregnancy test (urine) (females) 12. Alcohol consumption more than 28 units/week (males) or 21 units /week (females) (1 unit of alcohol equals 10 grams of ethanol) 13. Recent blood donation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study objective is to establish the systemic exposure of consumers to a toluene-2,5-diamine containing hair dye formulation under actual use conditions during a typical hair dyeing procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed