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

Interdos Pharma bv0 个研究点目标入组 170 人开始时间: 2007年12月5日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•- 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.
•- Subjects whose medical condition (including laboratory testing results) may interfere with the objective of the study, according to the opinion of the investigator.

发起方

Interdos Pharma bv