doubleblind (observer blind), placebo-controlled, clinical-experimental study phase II in order to examine the local compatibility of Dr. Theiss Ringelblumen Salbe N by the duhring-chamber-test and in a open user trial - local compatibility test and open user trial with Dr. Theiss Ringelblumen Salbe N

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004466-33-DE

Enrollment

Registered

2006-01-09

Start date

2005-08-01

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy subjects with normal skin conditions

Interventions

Trade Name: Dr. Theiss Ringelblumen Salbe N (earlier: Apia Calendula Salbe) Product Name: Dr. Theiss Ringelblumen Salbe N Pharmaceutical Form: Cream Pharmaceutical form of the placebo: Cream Route of

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) no 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 dieseases or dermatological disorders Volunteeers with severe disorders Topical medication in the test areas Participation in an study in the last 4 weeks 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 trial with possible patch test: irritation exclusion of a possible sensitation	—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026