E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bacterial infected eczemas |
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E.1.1.1 | Medical condition in easily understood language |
Eczemas with an additional problem: A bacterial infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10014199 |
E.1.2 | Term | Eczema infected |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Depends on the secondary endpoint, see E.5.2 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |