Patch test on normal skin of healthy volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers that fulfill the following inclusion criteria: •male and female volunteers older than 18 years •ability to give written informed consent •ability to adhere to the directions and conditions of the study
Exclusion criteria
Exclusion criteria: General exclusion criteria •reduced general condition •participation in other clinical trials during the last 4 weeks •volunteers that can not comprehend and adhere to the conditions of the study specific exclusion criteria •dermatological skin disorder requiring specific therapy •known intolerance of any component of the study preparation •medical co-medication with anti-inflammatory, immuno-modulatory or antibiotic drugs (i.e. antibiotcs, antihistamines, glucocorticoids or immunosuppressive drugs).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the UV induced skin erythema (UV erythema test) by the test preparations in comparison to placebo after 48 h. Skin erythema is measured photometrically after 48 h using a Mexameter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin tolerability of the test preparations determined in the occlusive patch test on non irradiated skin after 48 h. Skin erythema is measured photometrically after 48 h using a Mexameter. | — |
Countries
Germany
Contacts
Klinik für Dermatologie und Venerologie