EUCTR2014-005519-18-DE进行中（未招募）1 期
Double-blind, randomised clinical study comparing efficacy and safety of Gentamicin 0.1%_Betamethasone 0.05% Ointment (Test) vs. Diprogenta(R) Ointment (Reference) vs. Vehicle in patients with bacterial infected eczema
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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