E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with mild to moderate dermatitis meeting Hanafin and Rajka´s Criteria with at least two comparable lesional areas of 20-50 cm2. |
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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 | 10003641 |
E.1.2 | Term | Atopic eczema |
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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 assess the clinical skin condition after treatment with a topical riluzole formulation in subjects with atopic eczema |
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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 volunteer in the study: • signed written informed consent obtained; • male or female subjects, 18 to 64 years; • manifest atopic dermatitis diagnosed according to Hanifin and Rajka (3); • two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate; • TEWL in the lesional areas at least 12 g/m²h, TEWL value differences ≤ 30 % are allowed between both lesional areas; • the physical examination must be without further disease findings unless the investigator considers an abnormality to be clinically irrelevant; • sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen: systemic contraceptive (combined oral contraceptive, implant, injection), safe intrauterine device (IUD).
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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: • acne, suntan, eczema other than Atopic eczema, hyper- or hypopigmentation or tattoos in the treatment 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; • participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study; • symptoms of a clinically significant illness that may influence the outcome of the study in the month before and during the study; • known allergic reactions to components of the study preparations; • liver disease or transaminase values > 3 times upper normal limit; • kidney insufficieny; • neutropenia; • systemic treatment or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids or medication that influences liver function) within four weeks before first study treatment (exception: asthma may be found in subjects with atopic dermatitis, therefore inhalation with corticosteroids in subjects with asthma accompanying atopic dermatitis will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period); • 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) |
The primary endpoints are • clinical assessment (erythema, edema/infiltrate, excoriations, papules) by scoring • calculation of epidermal barrier impairment by measurement of transepidermal water loss (TEWL) • evaluation of skin redness by chromametry • subjective assessment of itching and burning • safety laboratory • evaluation of blood levels of active ingredient
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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 | Yes |
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) | 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) | 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
| 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 end of the trial is the last visit of the last subject. |
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |