E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dermatitis atópica leve a moderada. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
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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 primary objective of the study is to show therapeutic efficacy of Zarzenda® cream versus Elidel® 1% cream in children and adolescents with mild to moderate atopic dermatitis . |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Fully informed written consent of the legal representative and assent of the patient 2. Mild to moderate atopic dermatitis according to the Investigator’s Global Assessment (IGA 3 or 4) 3. History of atopic dermatitis for at least one year 4. Age of 2 – 17 years at baseline 5. Affected Body Surface Area (BSA): minimum of 5% 6. Patients in whom a treatment with topical corticosteroids is not recommended or is not possible, i.e. due to intolerability of topical corticosteroids, due to lack of efficacy of topical corticosteroids, due to use in the face and the neck where the use of topical corticosteroids is not recommended. 7. Wash out periods to be observed before start of study medication: • 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 last 4 weeks have passed since any vaccination • At least 4 weeks have passed since local AD therapy using tacrolimus or pimecrolimus • At least 2 weeks have passed since antihistaminic therapy, unless taken regularly during the previous year • At least 2 weeks have passed since local AD therapy using corticosteroids 8. At least 4 weeks have passed since participation in an investigational drug study 9. Willingness to follow all study procedures 10. Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
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E.4 | Principal exclusion criteria |
1. Pregnancy (in patients with childbearing potential), breast feeding 2. Indication for systemic therapy of the atopic dermatitis 3. Known sensitivity to Zarzenda®, and / or to any excipients of the formulation and/or to an extract of the nut butyrospermum parkii (shea) 4. Known sensitivity to macrolides 5. Lymphadenopathy 6. Known immune deficiency 7. Known hepatic insufficiency 8. Known renal insufficiency 9. Patients with severe excoriations 10. Patients with clinically active skin infection (e.g. acute and severe impetigo contagiosa) 11. Acute herpes simplex, mononucleosis, or mollusca contagiosa infection 12. Severe other viral, bacterial, or fungal skin infection (chicken pox, tinea corporis) 13. Acute infestations (e.g. head lice, scabies) 14. Generalized erythroderma, Netherton’s syndrome, 15. Any conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 16. Patient is a dependent person, e.g., a relative / family member of the investigator and / or is a member of the investigator’s staff
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be the Investigator's Global Assessment (IGA) dichotomized as ‘success/failure’ by combining the scores in ‘clear’/‘almost clear’ and ‘mild’/‘moderate’/ ‘severe’/‘very severe’. The Investigator Global Assessment (IGA) score will be assessed at baseline and at each treatment visit. The investigator will assess the current overall clinical picture of the patient, i.e. the Investigator’s Global Assessment is a static score which takes into account only the actual disease severity. The use of a static score has the advantage that the investigator does not need to remember the individual baseline of a patient. |
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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 | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 | No |
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 | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |