Role for pimecrolimus in restoring skin barrier function and normalizing epidermal lipid content and differentiation in atopic epidermis: a randomized, intra-patient, double-blind (right/left arm) study in adults with atopic dermatitis treated with 1% pimecrolimus cream and 0.1 % betamethasone cream as treatment control twice daily for 3 weeks - Pimecrolimus and Epidermal Barrier Function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004824-11-DE

Enrollment

Registered

2005-10-04

Start date

2005-04-15

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

Atopic Dermatitis

Interventions

Trade Name: Elidel 1% Cream Product Name: Elidel 1 % cream Pharmaceutical Form: Cream Trade Name: Betnesol V-Creme 0.1 % Product Name: Betnesol-V-cream 0.1 % Pharmaceutical Form: Cream

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults with atopic dermatitis of mild to moderate severity. 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients who are pregnant, nursing, immunocompromised or presenting signs of skin atrophy.

Design outcomes

Primary

Measure	Time frame
Main Objective: Examination of the treatment mechanism of pimecrolimus on epidermal barrier function in atopic dermatitis.;Secondary Objective: Examination of epidermal cell proliferation and cell differentiation.;Primary end point(s): Improvement/change in values for transepidermal water loss in the skin (TEWL).	—

Countries

Germany

Outcome results

None listed

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