Double blind (observer Blind) Placebo controlled, clinical-experimental Study of the Phase II for the examination of the local tolerance by Duhring-Chamber-Test as well as open user trial of the product Arnikamed Gel
- Conditions
- healthy subjects with normal skin conditions
- Registration Number
- EUCTR2004-004511-39-DE
- Lead Sponsor
- Dr. Theiss Naturwaren GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>User tral with possible patch test:<br>irritation exclusion of a possible sensitisation
- Secondary Outcome Measures
Name Time Method