E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 goal of this study is to assess whether the clinical efficacy and safety of Fusidic acid hydrophilic cream 20 mg/g, manufactured by Basic Pharma Manufacturing bv, and Fucidin are equivalent in a 7-day treatment of impetigo in adult and paediatric subjects.
Primary outcome: cure after 1 week. Cure is defined as the complete absence of lesions or the lesions having become dry and without crusts; remaining local erythema of the intact skin is acceptable. |
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E.2.2 | Secondary objectives of the trial |
Secondary outcomes: - Improvement: decline in the affected area, number of lesions or both - Bacterial cure: elimination of causative pathogens in persisting lesions or the unavailability of a swab if lesions were cured - Safety evaluation: comparison of tolerance and adverse event profiles
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Subjects having a clinical diagnosis of localised impetigo contagiosa (not the extensive forms) - Subject age: more than 18 months
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E.4 | Principal exclusion criteria |
- Subjects whose temperature >38.5 degrees C - Subjects who have extensive forms of impetigo, or other infections of deeper skin structure, that require systemic treatment - Subjects with secondary impetigo, where the infection is secondary to some other underlying skin disease, such as scabies or eczema - Subjects with sunburn and those who may have considerable exposure to sunlight, including UV lamps, during the study period - Subjects who have a history of hypersensitivity to fusidic acid or any of the components of the study medication - Other disease: subjects with a recent history (within 3 months prior to enrolment) of severe systemic disease. - Other medication: 1) For 24 hours prior to entry, subjects should not have been treated with topical steroids, topical retinoids, or topical antibiotics 2) For 1 week prior to entry, subjects should not have utilised medicated shampoos or medicated cleansers of any type. Non-medicated cleansers and emollients are permitted at the discretion of the investigator. 3) For 1 month prior to entry, subjects should not have been treated with UV-lamp irradiation, systemic antibiotics, or parenteral corticosteroids. - Subjects whose medical condition (including laboratory testing results) may interfere with the objective of the study, according to the opinion of the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome: cure after 1 week. Cure is defined as the complete absence of lesions or the lesions having become dry and without crusts; remaining local erythema of the intact skin is acceptable. |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Yes |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
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) | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
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 study is completed when the last included subject has completed the study according to the protocol. |
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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 | 5 |
E.8.9.1 | In the Member State concerned days | |
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 | 5 |