A 12 week multicenter study consisting of a 6 week double blind, randomized, vehicle controlled, parallel group phase, followed by a 6 week open label phase, to assess the efficacy and safety of Elidel® Cream 1% in mild to moderate facial atopic dermatitis of patients (2 to 11 years of age, inclusive) intolerant of, or dependent on, topical corticosteroids

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001650-25-DE

Enrollment

216

Registered

2005-08-12

Start date

2005-11-24

Completion date

Unknown

Last updated

2012-12-17

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

Conditions

Mild to moderate facial atopic dermatitis (AD), in children

Interventions

Trade Name: Elidel 1% Creme Product Name: Elidel 1% Creme Product Code: ASM981 Pharmaceutical Form: Cream INN or Proposed INN: pimecrolimus CAS Number: 137071-32-0 Current Sponsor code: ASM981 Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 2 to 11 years of age, inclusive - Mild to moderate facial AD at screening (facial IGA 2 – 3; based on assessment of the face only and excluding the ears and the neck). - Patients intolerant of, or dependent on, topical corticosteroids - Diagnosis of AD fulfilling the Hanifin and Rajka criteria - For female patients, a negative pregnancy test. Women who are pregnant or who are breast-feeding may not be included in the study. Women of child-bearing potential must follow a medically recognized form of contraception. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: At baseline, patients : - with AD on greater than 30% of total body surface area - with concurrent skin disease (e.g. acne) in the study area or active skin infections or other conditions that may interfere with the evaluation - who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or with a history of malignant disease - with previously reported poor, no clinical response or hypersensitivity to topical calcineurin inhibitors such as pimecrolimus cream (Elidel®) and tacrolimus cream (Protopic®) - who received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g. immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 2 - who received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study - who are unlikely to comply with therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of Elidel® Cream 1% vs. vehicle on the face of mild to moderate AD patients (2 to 11 years, inclusive) who are intolerant of, or dependent on, topical corticosteroids by testing the hypothesis that a greater percentage of patients treated with Elidel® vs. vehicle will achieve treatment success, defined as a facial Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear), during the 6-week double-blind phase. A facial IGA is an assessment of the face only, and does not include the ears or the neck.;Secondary Objective: To determine the effect of Elidel® vs. vehicle on the overall Eczema Area Severity Index (EASI) score, head and neck EASI score, pruritus score, and time to clearance of facial AD (i.e., a facial IGA score of 0) during the 6-week double-blind phase. In addition, study drug utilization, Eyelid Dermatitis Assessment (EDA) score, safety and tolerability will be assessed at the end of 6 and 12 weeks.;Primary end point(s): Percentage of patients achieving treatment success, defined as a facial Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear) during the 6-week double-blind phase. A facial IGA is an assessment of the face only, and does not include the ears or the neck.	—

Measure

Time frame

Main Objective: To determine the efficacy of Elidel® Cream 1% vs. vehicle on the face of mild to moderate AD patients (2 to 11 years, inclusive) who are intolerant of, or dependent on, topical corticosteroids by testing the hypothesis that a greater percentage of patients treated with Elidel® vs. vehicle will achieve treatment success, defined as a facial Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear), during the 6-week double-blind phase. A facial IGA is an assessment of the face only, and does not include the ears or the neck.;Secondary Objective: To determine the effect of Elidel® vs. vehicle on the overall Eczema Area Severity Index (EASI) score, head and neck EASI score, pruritus score, and time to clearance of facial AD (i.e., a facial IGA score of 0) during the 6-week double-blind phase. In addition, study drug utilization, Eyelid Dermatitis Assessment (EDA) score, safety and tolerability will be assessed at the end of 6 and 12 weeks.;Primary end point(s): Percentage of patients achieving treatment success, defined as a facial Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear) during the 6-week double-blind phase. A facial IGA is an assessment of the face only, and does not include the ears or the neck.

—

Countries

Germany

Outcome results

None listed

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