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 | 8.1 |
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 |
To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks. |
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E.2.2 | Secondary objectives of the trial |
To compare the safety LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with atopic dermatitis after once daily treatment for three weeks.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Signed informed consent has been obtained following verbal and written information about the trial 2. Clinical diagnosis of atopic dermatitis according to Hanifin and Rajka (see Appendix III) 3. The score of each of the five clinical signs in Total Severity Score on the arms should be ≥2 (moderate) at Visit 1 4. Treatment area amenable to topical treatment 5. Male gender 6. Age between 18-50 years 7. Attending a hospital outpatient clinic or the private practice of a dermatologist
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E.4 | Principal exclusion criteria |
1. Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or in-tranasal steroids for asthma or rhinitis may be used) 2. PUVA or UVB therapy within 4 weeks prior to randomisation 3. Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or cortico- steroids from WHO groups III or IV within 2 weeks prior to randomisation 4. Other topical therapy on the treatment area (except for the use of emollient on the entire body and hydrocortisone cream 1% on head and neck lesions) within 1 week prior to randomisation 5. Use of any other kind of treatment for AD (drug , non-drug) during the study except for the use of: - investigational product on trunk and limbs lesions only during the treatment phase - hydrocortisone cream 1% on head and neck lesions - emollient on the entire body 6. Use of anti-histamines during the study 7. Current diagnosis of exfoliative erythrodermia 8. Clinical infection (impetiginised atopic dermatitis) on the treatment area 9. Planned exposure to amount of sun or ultraviolet light during the study that may affect atopic dermatitis 10. Known or suspected hypersensitivity to component(s) of the investigational product 11. Known or suspected severe renal insufficiency or severe hepatic disorders 12. Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia 13. Patients with history of cancer including skin cancer 14. Patients with history of an immunocompromised disease (e.g. lymphoma, HIV, Wiskott-Aldrich Syndrome) 15. Current participation in any other interventional clinical trial 16. Patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registra-tion) within 4 weeks prior to randomisation 17. Previously randomised in this study 18. Patient known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state)
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E.5 End points |
E.5.1 | Primary end point(s) |
The absolute change in Total Severity Score on the target area (the arms) from baseline to end of treatment. |
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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 | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |