E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe atopic dermatitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
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 |
The objective of this study is to compare the efficacy and safety of tacrolimus 0.03% ointment versus fluticasone 0.005% ointment, administered in accordance with the conditions of their respective marketing authorisations. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Only those patients complying with the criteria below may be included:
-Male or female patients, of any racial origin,
-Patients aged between 2 and 15 years (not yet celebrated their 16th birthday) suffering from moderate to severe atopic dermatitis (Rajka & Langeland score ≥ 4.5 – see Annex C) and who have responded insufficiently to conventional therapies.
-Female patients of childbearing age must undertake to use, if relevant, effective contraceptive measures throughout the period of the study and for the four weeks following the end of the study.
-Children whose parents have signed the informed consent form. In this case, and if the child is capable of understanding the aims and risks inherent in the study, his or her written informed consent should also be obtained.
-Patients complying with the following criteria for therapeutic washout: Treatment restrictions prior to the study: Washout period before Day 1 Topical corticosteroids: 3 days Systemic corticosteroids for the treatment of atopic dermatitis: 5 days Non-steroidal immunosuppressants (cyclosporin, methotrexate, etc.): 2 weeks Systemic antihistamines: 5 days Other study drugs: 4 weeks UVA/UVB therapy: 4 weeks Treatment with Tacrolimus ointment or Pimecrolimus: 2 weeks Topical antibiotics: 3 days
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E.4 | Principal exclusion criteria |
Patients presenting with any one of the following criteria cannot be included in the study:
-Patients with a genetic epidermal barrier defect, such as Netherton's syndrome, or those suffering from erythroderma.
-Any female patients who are pregnant or breast-feeding.
-Patients presenting with a clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum.
-Patients presenting with superinfected eczema.
-Patients presenting with known hypersensitivity to macrolides or to any other excipient in tacrolimus ointment.
-Patients presenting with known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation.
-Patients presenting with ulcerated lesions, of whatever type.
-Patients presenting with moderate to severe acne with rosacea.
-Patients participating at the same time in another clinical study or who have participated in another clinical study within 28 days of the start of this study.
-Patients presenting with any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, may interfere with the patient's follow-up.
-Patients with known serologically-proven HIV positivity.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy will be judged from the mEASI score (modified Eczema Area and Severity Index, described in Annex C), assessed at week 3 (D21), the primary endpoint being the number of patients presenting with a 60% improvement in their mEASI score at week 3, versus D1. |
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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 | Yes |
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 | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |