E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
volunteers with psoriasis vulgaris in a cronic stable phase and stable plaques with an area sufficient for 3 treatment fields |
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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 | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
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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 determine the non-inferiority of a new topical corticsteroid formulation vs the marketed product Ecural® Fettcreme in a psoriasis plaque test |
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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 |
All of the following criteria have to be met for inclusion of a subject in the study: • men and women aged 18 to 75; • subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for three treatment fields separated by at least 2 cm; • the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; • female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner; • written informed consent obtained.
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E.4 | Principal exclusion criteria |
Subjects are to be excluded from the study when one or more of the following conditions are met: • subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis; • local treatment with antipsoriatics (like vitamine D, dithranol, glucocorticosteroids; except for salicylic acid in vaseline) in the 4 weeks preceding and/or during the study; and any topical antipsoriatic treatment on the plaques to be treated in this study (including corticosteroids, except for salicylic acid) in the 8 weeks preceding and/or during the study; • systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics in the three months preceding and during the study; • treatment with systemic or locally acting medications which might counter or influence the study aim (medications which are known to provoke or aggravate psoriasis, e.g. beta-blocker, antimalarial drugs, lithium) within eight weeks before the beginning of the study and/or during the study; • known allergic reactions, irritations or sensitivity to the active ingredients or other components of the study preparations or comparators, hypersensitivity against cetylstearyl alcohol; • evidence of drug or alcohol abuse; • pregnancy or nursing; • UV-therapy within four weeks before beginning and during the study; • symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study; • participation in another clinical trial involving pharmaceutical products in the four weeks preceeding and/or during the study; • in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; • subject is institutionalized because of legal or regulatory order.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy variable for this study is the area under the curve (AUC) calculated from the changes to baseline in infiltrate thickness. A secondary endpoint is the superiority of Mometasone cream, 0.1 % mometasone furoate to the active ingredient-free vehicle to Mometasone cream with respect to the AUC of change to baseline in infiltrate thickness. |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
intraindividual comparison of treatments |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 2 |