EUCTR2009-011931-11-DE进行中（未招募）不适用
Explorative, double-blind, randomized, controlled multi-center phase II study to evaluate the efficacy and safety of topically applied combinational product LAS41003 once daily versus corresponding mono-preparations in the treatment of superficial infected eczema - LA 41003
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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.Signed and dated written informed consent
- •2.Caucasian male and female patients
- •3.Aged = 18 years
- •4.Have at least one clinically diagnosed superficial infected eczema confirmed by the following symptoms:
- •exudation/crusting
- •The cumulative score for these symptoms is at least grade 6 (according to a 4-point severity score used for grading each of the symptoms; Intensities: None = 0, Mild = 1, Moderate = 2, Severe = 3).
- •5.The minimal area of the target eczema (selected for complete efficacy evaluation) is not less than 2 cm2
- •6.Physical ability to apply the study preparations correctly and to follow the study restrictions and visits
- •7.Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known hypersensitivity, intolerance or allergies against Octenidine, Prednicarbate or other ingredients of the investigational medicinal products (e.g. cetearyl alcohol etc.)
- •2.Patients who have general signs of systemic infections like fever, malaise, lymphagitis or swollen lymph nodes and/or need systemic antibiotic treatment
- •3.Patients who have a bacterial skin infection which, due to depth and severity, could not be appropriately treated with a topical antimicrobial or antiseptic medication
- •4.Have evidence of clinically significant or unstable medical conditions such as:
- •metastatic tumor or tumor with high probability of metastatic spread
- •immunosuppressive disorder (e.g. HIV)
- •hematologic, hepatic, renal, neurologic or endocrine disorder
- •insulin-dependent diabetes mellitus and/or hypoglycaemia if unstable or clinically manifested even under treatment
- •5.Diagnose of the following disease:
- •Known active tuberculosis or any history of past tuberculosis of skin
- •Suspected or proven parasitic infection of the treatment
- •treatment site (e.g. scabies)
- •Suspected or proven viral infection of skin (e.g. Herpes)
- •6.Localization of the eczema:
- •palms of the hands
- •sole of a foot
- •7.An area of more than 8 palms (corresponding to a body surface area of about 1200 cm2) is covered with superficial infected eczema
- •8.Have received the following topical treatments for any indication in the treatment areas within the designated time period before treatment with investigational medicinal product (IMP):
- •Treatment Time Period
- •Topical antibiotics 6 weeks
- •Topical antimycotics 2 weeks
- •Topical steroids 2 weeks
- •Topical immunomodulators 2 weeks
- •Antiseptic agents 1 week
- •9.Have received the following systemic treatments within the designated period before treatment with IMP:
- •Treatment Time Period
- •Interferon 6 months
- •Cytotoxic drugs 6 months
- •Immunomodulators or
- •immuno-suppressive therapies 3 months
- •Drugs known to have
- •major organ toxicity 4 weeks
- •Antibiotics 4 weeks
- •Antimycotics
- •Corticosteroids (oral or injectable) 4 weeks
- •Inhaled corticosteroids 4 weeks
- •(>1200 microg/day for beclomethasone, or >600 microg/day for fluticasone)
- •Antihistamines 48 hours
- •10.Have received any topical treatment with antibiotics, antimycotics, immunomodulators and corticosteroid preparations within the last 2 weeks before treatment with IMP
- •11.Any topical treatment with antiseptics agents within one week before treatment with IMP
- •12.Patients having any significant physical abnormalities (e.g. tattoos) in the potential treatment area that may cause difficulty with examination or final evaluation
- •13.Patients not willing to stop using skin care products (including sunscreens and make-ups) and washing products during the study within the treatment areas
- •14.Have any dermatological disease in the treatment areas or surrounding area that may be exacerbated by treatment with topical Pre
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