E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe atopic dermatitis and presenting with so-called "red face" lesions of the head and neck. |
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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 0.1% ointment versus fluticasone 0.005% ointment, administered in accordance with the terms of their respective marketing authorisations, and assessed on facial lesions only.
NB: the words "face" or "facial" are used to locate lesions situated on the "head, neck, chest and/or nape of neck". |
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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 patients who comply with all the criteria below may be included:
-Male or female patients, of any racial origin.
-Patients over the age of 16 years (after 16th birthday), presenting with moderate to severe atopic dermatitis with lesions to the head and neck defined as "red face" or "facial eczema": erythema affecting at least 10% of the surface of the "face" (head, neck, chest, nape of neck), accompanied by itching and also, in some cases, by oedema, vesicles, dryness, weeping, crusts and lichenification in a context of longstanding atopic dermatitis, accompanied or not by lesions on the body. These patients have experienced at least two flare-ups of "facial" eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment has proved ineffective or poorly tolerated.
-Female patients of childbearing age must, if relevant, undertake to use effective means of contraception throughout the period of the study and for four weeks following the end of the study.
-Patients who have signed the informed consent form (see section 15.3 and Annex G)
-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 + Pimecrolimus: 2 weeks Topical antibiotics: 3 days
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E.4 | Principal exclusion criteria |
Patients presenting with at least 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.
-Patients presenting with seborrheic dermatitis or contact dermatitis affecting the "face", or any other facial erythema of non-atopic origin.
-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 0.1% 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 mLEASI score (modified local Eczema Area and Severity Index, calculated solely for the "face"), assessed at week 3 (D21). The primary endpoint of this study is the percentage of patients presenting at the week 3 visit (D21) with an improvement of at least 60% in the local mEASI score (mLEASI), by comparison with 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 | 9 |
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 |