Clinical study to compare two creams with the active substance gentamicin and betamethason and one cream without active substance for patients with bacterial infected eczema

Phase 1

• Conditions: Bacterial infected eczemas; MedDRA version: 18.1Level: PTClassification code 10014199Term: Eczema infectedSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-005518-44-DE
• Lead Sponsor: Dermapharm AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-29
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

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 guideline 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

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 inclusion
9) Known intolerance or hypersensitivity against gentamicin or other aminoglycosids, betamethasone or other glucocorticoids, chlorocresol, parabenes 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 measurements used in ths 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

Study & Design

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