EUCTR2008-002765-31-DE进行中（未招募）不适用
A multicenter, randomized, double-blind, placebo-controlled, intraindividual-comparison phase IIa trial to evaluate the efficacy and safety of 2% AVT-02 UE ointment in an every other day treatment of mild to moderate psoriasis vulgaris
Avontec GmbH0 个研究点开始时间: 2008年5月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- Male
入选标准
- •- Male, aged between 18 and 75 years
- •- subjects must habe a diagnosis of mild to moderate plaque-type psoriasis (PASI <= 10)
- •- >= 2 symmetrical psoriasis lesions on the extremities each of at least 12 cm2
- •- Written informed consent
- •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
- •- Male, aged between 18 and 75 years
- •- subjects must habe a diagnosis of mild to moderate plaque-type psoriasis (PASI <= 10)
- •- >= 2 symmetrical psoriasis lesions on the extremities each of at least 12 cm2
- •- Written informed consent
- •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
- •?Significant skin diseases (other than plaque-type psoriasis), especially any condition (including atopy and related disorders) or treatment that may interfere with the skin barrier function and/or may have an influence on the immune response
- •?Significant medical condition or treatment that may have an influence on the immune response (e.g. auto immune diseases)
- •?Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- •?Screening laboratory values > Grade 1 (according to WHO Toxicity Criteria by Grade)
- •?Administration of any biologic within 3 months prior to study entry
- •?Administration of any other systemic anti-psoriatic drug (such as systemic corticosteroids, ciclosporin, MTX, fumaric acid esters) within 30 days prior to study entry
- •?Phototherapy (e.g. UVB, PUVA) within 14 days prior to study entry
- •?Administration of any topical anti-psoriatic drug within 14 days prior to study entry
- •?Known adverse reactions of any severity or hypersensitivity to any ingredient of 2% AVT-02 UE ointment
- •?History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases (e.g. multiple sclerosis)
- •?Blood donation and loss of more than 400 ml 8 weeks prior to inclusion into study
- •?HIV infection (has to be excluded by laboratory test prior to randomization)
- •?Other active infectious diseases
- •?Alcohol abuse (has to be excluded by laboratory test prior to randomization)
- •?Major surgery 4 weeks prior to inclusion into study
- •?Vaccination with 6 days prior to enrolment and during the study
- •?Excessive UV-exposure 4-weeks prior to enrolment and during the conduct of the study
- •?Subjects with partner of child-bearing potential and their partners should use a highly effective method of birth control (failure rate < 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •?Subjects who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with the conduct of the trial
- •?Participation in any other clinical trial within 4 weeks prior or during this trial
- •?Significant skin diseases (other than plaque-type psoriasis), especially any condition (including atopy and related disorders) or treatment that may interfere with the skin barrier function and/or may have an influence on the immune response
- •?Significant medical condition or treatment that may have an influence on the immune response (e.g. auto immune diseases)
- •?Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- •?Screening laboratory values > Grade 1 (according to WHO Toxicity Criteria by Grade)
- •?Administration of any biologic within 3 months prior to study entry
- •?Administration of any other systemic anti-psoriatic drug (such as systemic corticosteroids, ciclosporin, MTX, fumaric acid esters) within 30 days prior to study entry
- •?Phototherapy (e.g. UVB, PUVA) within 14 days prior to study entry
- •?Administration of any topical anti-psoriatic drug within 14 days prior to study entry
- •?Known adverse reactions of any severity or hypersensitivity to any ingredient of 2% AVT-02 UE ointment
- •?History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases (e.g. multiple sclerosis)
- •?Blood donation and loss of more than 400 ml 8 weeks prior to inclusion into study
- •?HIV infection (has to be excluded by laboratory test prior to randomization)
- •?Other active infectious diseases
- •?Alcohol abuse (has to be excluded by laboratory test prior to randomization)
- •?Major surgery 4 weeks prior to inclusion into study
- •?Vaccination with 6 days prior to enrolment and during the study
- •?Excessive UV-exposure 4-weeks prior to enrolment and during the conduct of the study
- •?Subjects with partner of child-bearing potential and their partners should use a highly effective method of birth control (failure rate < 1% per year), such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
- •?Subjects who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment (including cosmetic products) that may interfere with the conduct of the trial
- •?Participation in any other clinical trial within 4 weeks prior or during this trial
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