E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
atopic dermatitis (atopic eczema) |
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MedDRA Classification |
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 |
The primary objective of this study is to determine the efficacy of Elidel® Cream 1% on the face of mild to moderate AD patients 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 a facial Investigators Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at the end of a 6-week period. 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 |
The secondary objectives of this study are 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 at the end of 6 weeks. In addition, health-related quality of life, study drug utilization, Eyelid Dermatitis assessment (EDA) score, skin atrophy and telangiectasia, 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 |
• 12 years of age or older • 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. “Medically recognized” contraception may, at the investigator’s discretion, include abstinence. |
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E.4 | Principal exclusion criteria |
At baseline and throughout the study, patients: • Who have AD on greater than 30% of total body surface area in addition to facial eczema • Who have concurrent skin disease (e.g. acne) in the study area or active skin infections (active bacterial, viral or fungal infections or infestations, herpes simplex, herpes zoster, chicken pox), or other conditions that may interfere with the evaluation (e.g. generalized erythroderma, Netherton’s syndrome) • Who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease (with the exception of treated basal-cell carcinoma) • Who have previously reported poor, no clinical response, or hypersensitivity to topical pimecrolimus cream (Elidel) • Who have 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 have 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) |
Investigators Global Assessment (IGA) of the face at week 6 (Day 43)
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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 | Yes |
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-wk double-blind phase followed by 6-wk open label treatment |
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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 | 0 |
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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |