EUCTR2010-018355-10-DE进行中（未招募）不适用
An Investigator-blind, Controlled Study to Assess the Efficacy of Five Distinct Combinations of LAS 41004 in Different Concentrations Compared to Placebo and to Two Active Controls in a Psoriasis-Plaque-Test
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 6 month
- •Psoriasis plaques that are suitable to be defined as target area lesions by the following criteria:
- •o Psoriasis plaques must be located at trunk and/or extremities. Plaques that are located on the head (incl. scalp), palms, sole of the feet, intertriginous or genitoanal areas are not suitable as target areas
- •o Comparable psoriasis plaques with at least 2” in each score (Range 0-4) for the three distinct symptoms scaling; erythema; and induration
- •o No more than 3 points difference in total score (= sum of scores for scaling, erythema and induration; range 0-12) of the chosen comparable psoriasis plaques
- •o Enough psoriatic surface area to define 8 clearly distinguishable (minimum distance between test areas: 1 cm) test areas of at least 1 cm² plaque size
- •Patient is willing and able to comply with the requirements of the clinical study protocol. In particular, patient must adhere to concomitant therapy prohibitions of the test areas and must agree to avoid intense UV exposure of the test areas during the study
- •Written informed consent to participate in the study, prior to any study related procedures, indicating an understanding of the purpose of the study
- •A patient of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study and the following 4 weeks after the end of study:
- •o Strict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed)
- •o Combined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance
- •o Intrauterine device (IUD) inserted for at least 1 month prior to study entrance
- •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
- •Too few body surface area covered with psoriasis plaques that meet the specified inclusion criteria to be defined as 8 clearly distinguishable test areas
- •Any condition that may interfere with the study assessments or sonographic measurements of the skin and/or may have an influence on skin immune response (incl. open wounds)
- •Known adverse reactions of any severity or hypersensitivity to any ingredient of the test products
- •No willingness to avoid induction of heavy sweating, e.g. due to sauna visits, excessive sports activities during the study course
- •No willingness to avoid swimming, bathing or wetting of the designated test areas between visits
- •Pregnant or breast-feeding women
- •A medical condition that may put the patient at a general risk and therefore would prevent participation in the clinical trial (including but not limited to: infectious diseases, major surgery within the last 4 weeks, coronary artery disease, renal impairment, hepatic impairment, uncontrolled metabolic diseases, disorders of the calcium metabolism, autoimmune diseases)
- •Significant skin diseases other than plaque-type psoriasis, incl. skin infections
- •History or presence of malignant disease (other than surgically removed basal cell carcinoma) and/or auto immune diseases
- •Current diagnosis of guttate, erythrodermic or pustular psoriasis
- •Patients who did not respect the following wash-out periods prior or during the study:
- •TreatmentWash out period
- •Topical treatment in the test area
- •Any topical anti-psoriatic drug2 weeks
- •Systemic treatment
- •Biologics6 months
- •Any other systemic treatment (corticosteroids, ciclosporin, MTX, fumaric acid esters)
- •Phototherapy 4 weeks
- •Excessive sunlight exposure within 28 days prior to study entry and during the conduct of the study
- •Usage of any topical formulation (incl. cosmetics, emollients, etc) on the designated target areas during the course of the study
- •Vaccination 6 days prior to enrolment or during the study
- •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 psoriasis or the conduct of the trial
- •Participation in any other clinical trial within 30 days prior or during this trial
- •Subject is an adult under guardianship, hospitalised, deprived of freedom or unable to communicate or cooperate with the investigator due to language or mental problems
研究者
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