Clinical study to compare two creams with the active substances fusidic acid and betamethasone and one cream without active substance for patients with bacterial infected eczemas.

• Conditions: Bacterial infected eczemas; MedDRA version: 17.1Level: PTClassification code 10014199Term: Eczema infectedSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-004370-28-DE
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-01
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of the efficacy and safety of a new fusidic acid 2% betamethosone 0.1% cream formulation vs. the originator Fucicort (licensed) vs. vehicle in patients with bacterial infected eczemas.<br><br>See also E5 (endpoints).;Secondary Objective: See E5 (endpoints).;Primary end point(s): Proportion of patients with clinical successful treatment on day 14 (end of treatment).<br>Clinical successful treatment means that the symptom exudate/purulence has disapeared completely and the SIRS score is less than 8 and no further treatment of the study indication is necessary. ;Timepoint(s) of evaluation of this end point: Day 14

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Score difference of the SIRS parameters in the different treatment groups at therapy start (day 0) and at main examination (day 14)<br>Course of all clinical parameters seperately and as sum score from inclusion examination (day 0) to final examination / early study termination <br>Clasification of the bacteriological success at end of treatment (day 14) and end of observational phase (day 21)<br>Number of patients with relapse / reinfection in the observational phase<br>Tolerance analysis:<br>Evaluation of tolerance<br>Adverse events, focussed on serious and/or unexpected adverse events, discontinuation of study medication due to adverse event, possible causal relation, patients with at least one adverse event, type and number of adverse events according to MedDRA;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2 above