EUCTR2010-024279-14-HU进行中（未招募）不适用
Double-blind, randomized, vehicle-controlled, multicenter, multinational, parallel-group study of the efficacy and safety of mapracorat ointment in concentrations of 0.01%, 0.03% and 0.1% over max. 4 weeks in subjects with Atopic Dermatitis (AD) - Efficacy and safety of different concentrations of mapracorat in AD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •Subjects must fulfill all of the following criteria before inclusion in the study:
- •1 Signed written informed consent
- •2 Male or female out-patient subject 18 to 65 years of age at screening (female subject either using an accepted effective method of contraception (failure rate of
- •< 1%,) or of non-childbearing potential, (this means post menopausal -one year without menstrual period))
- •3 Diagnosis of AD according to Hanifin and Rajka Criteria (Hanifin and Rajka 1980)
- •4 Static Investigator’s Global Assessment score = 3, corresponding to at least moderate AD at screening and start of treatment
- •5 Atopic dermatitis involving a minimum of 5% body surface area at screening and start of treatment
- •6 Willingness of subject to follow all study procedures
- •7 Willingness to avoid excessive exposure of diseased areas to natural or artificial sunlight
- •All parameters will be determined during the screening and baseline visit prior to first administration of the investigational product if not otherwise stated.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are to be excluded from the study if they display any of the following criteria:
- •Medical and surgical history
- •1 Pregnancy or lactation
- •2 Clinically relevant disease, which could interfere with the study conduct or the evaluation and interpretation of the study results
- •3 Clinically manifested immunosuppressive disorder or known history of malignant disease
- •4 Known hypersensitivity to any of the constituents or excipients of the investigational product (e.g. paraffin) or history of relevant drug and/or food allergies
- •Medication, drug use and special behavioral patterns
- •5 Use of any prescription or non-prescription medication prior to baseline that could interfere with evaluations in the study
- •At least 3 months have passed since any systemic interferon, immunomodulating or immunosuppressive treatment (excluding systemic AD therapy as listed in the following point)
- •At least 1 month has passed since any use of systemic AD therapy, in particular systemic corticosteroids, cyclosporine A, azathioprine, mycophenolate mofetil, or phototherapy
- •At least 2 weeks have passed since any local AD therapy, e.g. corticosteroids or topical immunomodulators
- •At least 2 weeks have passed since systemic or topical antibiotics
- •At least 1 week has passed since use of local anti-itch therapy (for example atopiclair)
- •Physical examination
- •6 Concomitant medical or dermatological disorder(s), which could interfere with the investigator’s ability to evaluate the subject’s response to the investigational product, e.g. chicken pox, impetigo, corticosteroid-induced perioral dermatitis, tinea corporis/tinea intertriginosa, recurrent active herpes simplex, head lice or scabies
- •Laboratory examination
- •7 Clinically relevant deviation in values for biochemistry, hematology, coagulation or urinalysis as judged by the investigator
- •8 Mental handicap, legal incapacity or limited legal capacity leading to inability to give informed consent, subject is institutionalized because of legal or regulatory order
- •9 Subject is a dependent person, this means a relative/family member of the investigator and/or a member of the investigator’s staff
- •10 Participation in another clinical research study within 4 weeks before enrollment in this study.
- •11 Previous assignment to treatment during this study
研究者
相似试验
进行中（未招募）
不适用
Double-blind, randomized, vehicle-controlled, multicenter, multinational, parallel-group study of the efficacy and safety of mapracorat ointment in concentrations of 0.01%, 0.03% and 0.1% over max. 4 weeks in subjects with Atopic Dermatitis (AD) - Efficacy and safety of different concentrations of mapracorat in ADAtopic DermatitisEUCTR2010-024279-14-DEIntendis GmbH200
进行中（未招募）
不适用
Double-blind, randomized, vehicle-controlled, multicenter, multinational, parallel-group study of the efficacy and safety of mapracorat ointment in concentrations of 0.01%, 0.03% and 0.1% over max. 4 weeks in subjects with Atopic Dermatitis (AD) - Efficacy and safety of different concentrations of mapracorat in ADAtopic DermatitisEUCTR2010-024279-14-LVIntendis GmbH200
进行中（未招募）
不适用
Double-blind, randomized, vehicle-controlled, multi-centric trial to prove the therapeutic efficacy and tolerability of a liquid acne topical containing Clindamycin phosphate and Sodiumbituminosulfonate, pale versus vehicle and versus each of the single active substances in mild to moderate acne vulgaris - liquid acne topical in mild to moderate acne vulgarisEUCTR2009-013273-17-CZIchthyol-Gesellschaft Cordes, Hermanni & Co. (GmbH & Co.) KG150
进行中（未招募）
1 期
Double-blind, randomized, vehicle-controlled, multi-centric trial to prove the therapeutic efficacy and tolerability of a liquid acne topical containing Clindamycin phosphate and Sodiumbituminosulfonate, pale versus vehicle and versus each of the single active substances in mild to moderate acne vulgaris - liquid acne topical in mild to moderate acne vulgarismild to moderate acne vulgarisEUCTR2009-013273-17-DEIchthyol-Gesellschaft Cordes, Hermanni & Co. (GmbH & Co.) KG150
进行中（未招募）
不适用
Double-blind, randomized, vehicle-controlled, multicenter, multinational, parallel-group study of the efficacy and safety of mapracorat ointment in concentrations of 0.01%, 0.03% and 0.1% over max. 4 weeks in subjects with Atopic Dermatitis (AD) - Efficacy and safety of different concentrations of mapracorat in ADMedDRA version: 13.1Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disordersAtopic DermatitisEUCTR2010-024279-14-CZIntendis GmbH200