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

• Conditions: Impetigo

• Registration Number: EUCTR2006-002528-41-NL
• Lead Sponsor: Interdos Pharma bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified