healthy subjects with normal skin conditions
Conditions
Interventions
Trade Name: Arnikamed Gel
Product Name: Arnikamed Gel
Pharmaceutical Form: Gel
Pharmaceutical form of the placebo: Gel
Route of administration of the placebo: Topical use (Noncurrent)
Sponsors
Dr. Theiss Naturwaren GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: written informed consent written informed data protection healthy subjects with healthy, normal skin conditions age more than 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: volunteers who do not fulfill any of the above described criteria volunteers who are pregnant or breast feeding skin irritation or disease skin diseases or dermatological disorders Volunteers with severe disorders topical medication in the test areas Participitation in a study in the last 6 months Consumption of alcohol or drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the local tolerance;Secondary Objective: exclusion of possible sensitisation;Primary end point(s): Duhring Chamber test: visual scoring of irritation, measurement of skin redness and trans epidermal water loss (TEWL) User tral with possible patch test: irritation exclusion of a possible sensitisation | — |
Countries
Germany
Outcome results
None listed