A comparison of the clinical efficacies of Fusidic acid hydrophilic cream 20 mg/g and Fucidin in the treatment of adult and paediatric patients with impetigo - FUSIDIC ACID CREAM STUDY

Interdos Pharma bv0 sites170 target enrollmentMay 17, 2006

Overview

No summary available.

Registry

who.int

Start Date

May 17, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Interdos Pharma bv

•\- 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

•\- 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.