Bacterial infected eczemas MedDRA version: 19.1 Level: PT Classification code 10014199 Term: Eczema infected System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Gentamicin 0.1%_Betamethasone 0.05% Ointment
Pharmaceutical Form: Ointment
CAS Number: 5593-20-4
Other descriptive name: BETAMETHASONE DIPROPIONATE
Concentration unit: % (W/W) percent we
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Women and men = 18 years of age 2) Written consent to study participation after patient information by the investigator 3) Diagnosis of bacterial infected eczema based on clinical symptoms in a treatment area between 5 and 25 cm2 4) At least moderately severe clinical picture, i.e. patients must have a SIRS score = 8. The SIRS (Skin Infection Rating Scale) score is defined as the sum score of the 7 clinical parameters exudate/pus, crusting, erythema, tissue warmth, tissue oedema, itching and pain (each symptom assessed on a scale ranging from 0 (= absent) to 6 (= severe)). 5) Presence of the clinical parameter “exudate/pus” (i.e. score = 1) 6) For women of childbearing potential : Application of an efficient contraceptive method (according to CPMP/ICH/286/95) during the whole study 7) For women of childbearing potential: Pregnancy test with negative result prior to study 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
Exclusion criteria: 1) Presence of a bacterial skin infection which, due to general criteria like severity or depth of the infection, cannot be treated adequately with topical antibiotics alone 2) Presence of any of the following skin conditions in the treatment area: viral infections (e.g. herpes simplex, herpes zoster), dermatomycosis, lues or tuberculosis of the skin, inoculation reactions, rosacea or rosacea-like dermatitis 3) Necessity of application of the study medication in the area around the eyes 4) Necessity of application of the study medication in the area around the ears 5) Necessity of application of the study medication near mucous membranes 6) Systemic therapy with antibiotics within the last 4 weeks before study inclusion 7) Systemic therapy with immunosuppressants or corticoids or medication with neuromuscular blocking effect within the last 2 weeks before study inclusion 8) Local treatment in the test area within the last week before study inclusion 9) Known intolerance or hypersensitivity against gentamicin or other aminoglycosids, betamethasone or other glucocorticoids, or any of the other ingredients in the study medications 10) Advanced renal insufficiency 11) Concomitant diseases like e.g. Myasthenia gravis, Parkinson or other neuromuscular disorders 12) Other severe acute or chronic concomitant disease with severe impairment of the general condition 13) Other concomitant diseases which may - taking the present knowledge into account - influence the parameters evaluated in the study in a way that an objective evaluation would be impossible 14) Necessity for a concomitant medication with neuromuscular blocking effect, e.g. benzodiazepines, or other central or peripheral muscle relaxants 15) Other concomitant medication which may - taking the present knowledge into account - influence the methods of measurement used in this study or the resulting data 16) Reasonable doubt concerning the co-operation of the patient 17) Participation in another clinical study within the last 30 days prior to inclusion in this study 18) Participation in this study at an earlier date 19) Women with existing or intended pregnancy or during lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of efficacy and safety of a new ointment with gentamicin 0.1% and betamethasone dipropionate 0.05% in comparison with the approved preparation Diprogenta® Ointment and the underlying vehicle in patients with bacterial infected eczema.;Secondary Objective: See also E5 (endpoints);Primary end point(s): The primary endpoint of the study is the clinical success rate at the end of treatment (Day 7 or Day 14). Clinical treatment success is defined as follows: - SIRS score < 8 - and score value for activity parameters exudate / pus = 0 - and no need for further treatment of study diagnosis;Timepoint(s) of evaluation of this end point: Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change of the SIRS score between visits, and between EOT and final examination 2) Number (percentage) of patients with bacteriological success at main examination (EOT) 3) Evaluation of therapeutic success at EOT by the investigator and by the patient 4) Evaluation of overall therapeutic success by the investigator at the final examination visit 5) Number (percentage) of patients with clinical relapse / re-infection at the final examination visit ;Timepoint(s) of evaluation of this end point: Depends on the secondary endpoint, see E.5.2 | — |
Countries
Germany
Contacts
Public ContactClinical Department
Dermapharm AG
Outcome results
None listed