EUCTR2010-022281-27-DE进行中（未招募）不适用
An Investigator-blind, Controlled Study to Assess the Efficacy and Safety of different formulations of LAS 41004 Compared to Placebo and to Active Control in a Psoriasis-Plaque-Test
相关药物
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
- •Inclusion Criteria
- •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:
- •oPsoriasis 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
- •oComparable psoriasis plaques with at least 2” in each score (Range 0-4) for the three distinct symptoms scaling; erythema; and induration
- •oNo 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
- •oEnough psoriatic surface area to define 5 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 highly effective contraceptive methods for the duration of the study and the following 4 weeks after study drug discontinuation:
- •oCombined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance, OR
- •oPartner who has been sterilized by vasectomy for at least 3 months prior to study entry, OR
- •oIntrauterine devices (IUD) inserted for at least 4 weeks prior to study entrance, AND
- •oBarrier methods (e.g. condom, cervical caps, diaphragm)
- •Note: The investigator must inform all female patients of childbearing potential that bexarotene can potentially induce metabolic enzymes and thereby theoretically reduce the efficacy of oestroprogestative contraceptives.
- •Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse for the duration of the study and for at least 4 weeks after the last dose of drug.
- •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 5 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 or other retinoid
- •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 (psoriasis vulgaris), including but not limited to: skin diseases in consequence of tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, dermatrophy, striae distensae, increased fragility of skin blood vessels, ichthyosis, ulcers, wounds,pruritus and reaction after vaccination
- •Skin infections (including but not limited to: herpes, varicella, mycotic skin infections, bacterial skin infections or parasitic 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 to study entry or do not restrain from using one of the following treatments 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 antipsoriatic treatment (corticosteroids, ciclosporin, MTX, fumaric acid esters)3 months
- •Phototherapy or artificial ultraviolet light 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
- •Vitamin A intake > 15,000 IU/day
- •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
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