E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012438 |
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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 |
Long term management of atopic dermatitis |
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E.2.2 | Secondary objectives of the trial |
Efficacy and safety of Advantan Creme |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
To be randomized, each patient must fulfill all of the inclusion criteria listed below. 1. Fully informed written consent of the legal representative and assent of the patient 2. Acute flare of atopic dermatitis according to the Investigator’s Global Assessment (IGA >= 4) ‘Severe’ or ‘Very Severe’ 3. History of moderate to severe form of atopic dermatitis for at least two years 4. Age of 12 years at Screening or older 5. Wash out periods to be observed before Baseline: - At least 4 weeks have passed since any use of systemic therapy for atopic dermatitis (AD), e. g., systemic corticosteroids (including inhaled or intranasal > 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy - At least 4 weeks have passed since any use of systemic AD therapy, e. g., systemic corticosteroids (including inhaled or intranasal > 1mg/d), cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy - At last 4 weeks have passed since any vaccination - At least 4 weeks have passed since local AD therapy using Protopic or Elidel - At least 2 weeks (4 weeks for Terfenadine) have passed since antihistaminic therapy, unless taken regularly during the previous year - At least 1 week has passed since local AD therapy using corticosteroids 6. At least 4 weeks have passed since participation in an investigational drug study 7. Willingness to follow all study procedures – including the self-responsible part of to decide what is considered a relapse |
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E.4 | Principal exclusion criteria |
For scientific and safety reasons and in accordance with the respective product information, patients exhibiting any of the criteria below are to be excluded from the Study: 1. Pregnancy, breast feeding 2. Any conditions that could interfere with any evaluation in the study 3. Indication for systemic AD therapy 4. Known sensitivity to Advantan, Advabase and / or to any content of the respective formulations 5. Known immune, hepatic, or renal insufficiency 6. Acute herpes simplex or mollusca contagiosa infection 7. Acute and severe impetigo contagiosa. A slight superinfection of eczema is no exclusion criterion 8. Severe other viral, bacterial, or fungal skin infection (chicken pox, prominent tinea corporis) 9. Acute infestations (e.g. head lice, scabies) 10. Any conditions that compromise the patient's ability to understand the patient information, to give informed consent/assent, to comply with the trial protocol, or to complete the study 11. Patient is considered a dependent person, e.g., a relative / family member and / or is a member of the investigator’s staff 12. Forfeited freedom by administrative or legal award or adult subject to administrative guardianship
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to relapse is the primary end point. It is defined as the number of days from End of AP (last continuous Advantan dose) until the disease relapses and the patient requests more intense treatment. The relevant date to calculate time to relapse is the date when the patient seeks treatment exceeding the maintenance regimen, not necessarily the installation of the new treatment. The patient should return to a visit to the investigator to raise this request, and the date will be recorded. Time to relapse will be calculated from the calendar dates by central study management, and not at the trial site. MP stops with this date, and the end of study medication visit is to be performed. If the patient concludes the scheduled 16 weeks MP without relapse, this fact will be recorded instead of a time to relapse.
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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 | Yes |
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 | 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 | 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) | 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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 9 |
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 | 9 |