E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Clinical condition of atopic eczema mild to moderate defined by a local SCORAD of at least 5 with • erythma ≥ 2 • lichenification ≥ 1 • dryness ≥ 1 • itching ≥ 1
• Erlangen atopy score sum equal or higher than 10 points
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
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 objective of the study is to evaluate the effects on clinical skin conditions and the satisfaction of customers of two different topical mometasone formulations in patients with mild to moderate atopic eczema |
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E.2.2 | Secondary objectives of the trial |
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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 patient in the study: • men and women aged 18 years or older; • two comparable treament areas (difference in local SCORAD not greater than 3) on opposite extremities of 100 - 300 cm2 with at least one lesional region within each of these areas of ≥ 20 cm². Clinical condition of atopic eczema mild to moderate defined by a local SCORAD of at least 5 with • erythma ≥ 2 • lichenification ≥ 1 • dryness ≥ 1 • itching ≥ 1 • Erlangen atopy score sum equal or higher than 10 points (3); • 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 |
Patients are to be excluded from the study when one or more of the following conditions are met: • acne, suntan, eczema, hyperpigmentation or tattoos in the test areas; • dark-skinned persons whose skin color prevents ready assessment of skin reactions; • evidence of drug or alcohol abuse; • pregnancy or nursing; • UV-therapy within 6 weeks before first treatment; • 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 the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study; • known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol; • treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. antihistamines or glucocorticosteroids) within two weeks before study day 1and throughout the study period (exception: asthma may be found in patients with atopic eczema, therefore inhalation with corticosteroids in patients with asthma accompanying atopic eczema will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period); • contraindications according to summary of product characteristics; • in the opinion of the investigator or physician performing the initial examination the patient should not participate in the study, e.g. due to probable noncompliance or inability to understand the study and give adequately informed consent; • patient is institutionalized because of legal or regulatory order.
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E.5 End points |
E.5.1 | Primary end point(s) |
No primary variable is prespecified. This study evaluates the assessment of cosmetic traits and efficacy only explorativly. |
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
patients´ satisfaction with the product |
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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 | 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) | 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 | 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 |
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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 | No |
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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The planed end of trial for a single patient is sudy day 15 unless he/she not meet the "Criteria for discontinuing in the case of individual patients" described in the protocol in section 5.3.7.2. |
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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 | 3 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |