Clinical trial on the efficacy of Calendula-Echinacea Ointment in sodium lauryl sulphate irritation test. A monocentric, randomised, placebo-controlled double blind clinical trial.
- Conditions
- healthy male and female volunteers with artificial damage to the skin barrier and irritative contact dermatitis after application of sodium lauryl sulphate
- Registration Number
- EUCTR2004-002767-25-DE
- Lead Sponsor
- WALA Heilmittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- healthy male and female volunteers from age 18 to 65
- no manifest skin diseases
- written consent to participation in the study after detailed information
- willingness to follow investigator instructions
- for women of childbearing potential: negative pregnancy test and effective method of birth control
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) no
F.1.3.1 Number of subjects for this age range
- infectious diseases
- serious state of health
- alcohol- or drug abuse
- participation in other clinical trials during the last four weeks or simultaneously to the current investigation
- concomitant use of cortocosteroids, antihistamines, medication with anti-inflammatory or antibiotic effect or psycho-drugs
- manifest skin diseases
- manifest inflammations
- known allergy to one of the components of the IMP or composite flowers
- pregnancy or nursing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method