E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | 10051890 |
E.1.2 | Term | Eczema impetiginous |
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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 and compare the eficacy (percent improvement) of each treatment with regard to individually measured signs of the disease (in a given target area) and assessed objectively by the investigator according to predefined scales. |
|
E.2.2 | Secondary objectives of the trial |
To assess the speed of action, measured as the number of days required to achieve total remission. Safety evaluations, including microbiological evaluation of impetiginous eczema lesion and cutaneous surrounding area and photographic records of the target area will also be done. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Mininum age 12 years old Good general health confirmed by clinical history and a physical and skin examination (excluding area of skin with impetiginous eczema) Diagnosis of impetiginous eczema. Ability to understand the procedures of the protocol and follow the requirements during the course of the study. Results of routine laboratory tests. This results must all be within normal limits or not clinically relevant in order to be included in the trial. |
|
E.4 | Principal exclusion criteria |
Pregnant patients or women of childbearing age who are not using birth control methods considered reliable by the attending physician. Patients with history of hypersensitivity to any of the components of the medication being studied. Patients in whom the extent or severity of the legions requires treatment of a different type than what is planned for this trial. Patients who need anyother type of topical or systemic medications during the trial that might affect the course of the disease. Patients who have been treated with other topical medication during the 14-day period prior to the start of the trial. Patients who have received systemic corticosteroids or any other immunosuppressant medication suring the 28-day period prior to the start of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Total remission of signs and symptoms after 5-28 days after treatment. The number of days to complete remission in each group will be compared using the One-Way ANOVA or a nonparametric test. Comparison of the safety profiles of the three therapeutic arms will be done using the chi-square test and One-Way ANOVA depending on each situation. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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 | Information not present in EudraCT |
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 | 7 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 |