E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate facial atopic dermatitis (AD), in children |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | M15 |
E.1.2 | Classification code | 10003639 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 corticosteroidscorticosteroids 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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
6 week double blind randomized period, followed by a 6 week open-label period |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |