Double-blind, randomized clinical trial to compare the efficacy and safety of fusidic acid 2% betamethasone 0,1% cream vs. Fucicort cream vs. vehicle for patients with bacterial infected eczemas.

Dermapharm AG0 个研究点开始时间: 2012年3月1日最近更新: 2014年12月1日

适应症

试验速览

暂无简介。

•1) Female or male, age at least 18 years
•2) Informed consent prior to study specific actions
•3) Diagnosis bacterial superinfected eczema based on the clinical symptoms with at treatment area between at least 5 cm² and 25 cm² at the most
•4) At least a moderate severe disease, that means a SIRS-Score of at least 8 (sum score of 7 clinical paramters: exudate/purulence, crusts, erythema, overwarming, swelling, itching, pain) evaluated on a scale 0-6
•5) Clinical Parameter exudate must be at least 1 =present
•6) Women of childbearing potential: Use of an efficient contraceptive method (according to guideline CPMP/ICH/286/95) during the study
•7) Women of childbearin potential: Pregnancy test with negativ result prior to therapy start
•Are the trial subjects under 18? no
•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 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1) Bacterial skin infection that can not be treated adequately with topical antibiotics due to its severity or the deepness of infection
•2) Suspicion for additional viral or mycotic infection in the treatment area
•3) Treatment with study medication in the area of the eyes
•4) Systemic treatment with antibiotics within the last 4 weeks prior to study inclusion
•5) Systemic treatment with immunosuppresive medication or corticosteroids within the last 2 weeks prior to study inclusion
•6) Topical treatment of the treatment area (s) within the last week prior to study inclusion
•7) Known intolerance or hypersensitivity against fusidic acid, betamethasone or against any of the other ingredienst of the study medication
•8) Severe actue or chronic concomitant disease seriously affecting the general condition
•9) Concomitant diseases which may -taking the present knwoledge into account- influence the parameters evaluated in the study in a way that an objective evaluation would be impossible
•10) Concomitant medication which may -taking the present knowledge into account- influence the methods of measurement used in this study or the resulting data
•11) Well-founded doubt regarding the cooperation of the patient
•12) Participation in another clinical trial within the last 30 days prior to inclusion or during this study
•13) Former participation in this clinical trial
•14) Pregnancy, planned pregnancy, lactation

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