Impetigo
Conditions
Interventions
Product Name: Fusidic acid hydrophilic cream 20 mg/g
Product Code: BPT05-641
Pharmaceutical Form: Cream
Sponsors
Interdos Pharma bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects having a clinical diagnosis of localised impetigo contagiosa (not the extensive forms) - Subject age: more than 18 months Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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 ;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. | — |
Countries
Netherlands
Outcome results
None listed