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Clinical trial on the efficacy of Calendula-Echinacea Ointment in sodium lauryl sulphate irritation test. A monocentric, randomised, placebo-controlled double blind clinical trial.

Clinical trial on the efficacy of Calendula-Echinacea Ointment in sodium lauryl sulphate irritation test. A monocentric, randomised, placebo-controlled double blind clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002767-25-DE
Enrollment
Unknown
Registered
2005-04-12
Start date
2005-03-21
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 male and female volunteers with artificial damage to the skin barrier and irritative contact dermatitis after application of sodium lauryl sulphate

Interventions

Trade Name: Calendula-Echinacea Salbe Product Name: Calendula-Echinacea Salbe Pharmaceutical Form: Ointment Other descriptive name: Calendula ex herba flor expressed plant juice with ethanol Concentra

Sponsors

WALA Heilmittel GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
Main Objective: Effect of the herbal drug preparations on transepidrmal water loss (TEWL) as an indicator for the damage of the skin barrier;Secondary Objective: Efficacy of the herbal drug preparations on the inflammation as compared to the ointment base (placebo), Hydrocortison acetas, Betamethasoni valeras and Dexpanthenolum;Primary end point(s): Effect of the herbal drug preparations on the TEWL (trans epidermal water loss)—

Countries

Germany

Outcome results

None listed

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