EUCTR2013-003757-22-DE进行中（未招募）1 期
A phase IIa, 28-day treatment, multi-center, randomized, comparator-controlled, observer-blind trial with intra-individual left/right comparison to investigate the anti-psoriatic efficacy and the safety of an LAS41004 formulation in comparison to an active reference in patients with mild to moderate plaque psoriasis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •men or women aged 18 years or older;
- •mild to moderate stable chronic plaque-type psoriasis with at least two symmetrical lesions with a treatment area of 20 – 300 cm² and a TSS of = 6;
- •the physical examination paying particular attention to the application area must be without further disease findings (other than psoriasis) unless the investigator considers an abnormality to be irrelevant to the outcome of the trial;
- •female volunteers of childbearing potential* must agree to use for one month prior to start of IMP application, during the trial and for at least one month after EoT reliable methods of contraception with a failure rate of less than 1 % per year (e.g. contraceptive implants of injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner). During the trial an additional barrier method (e.g. condoms) must be used. In the case of men with partners of childbearing potential* willingness of using condoms during the study conduct and for 1 month after end of treatment.
- •written informed consent obtained.
- •* Females NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy or tubal ligation) or who are postmenopausal (defined as continuous amenorrhea of at least two years)
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •severe forms of psoriasis or forms of psoriasis other than chronic plaque psoriasis, including:
- •-erythrodermic, exfoliative or pustular psoriasis;
- •-psoriatic arthritis;
- •-unstable psoriasis, with a change in severity within the last 6 weeks prior screening;
- •treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) which might counter or influence the trial aim within 2 weeks preceding the treatment phase of the trial and during the trial;
- •treatment with any systemic medications which might counter or influence the trial aim (including anti-psoriatics like corticosteroids, cytostatics or medications which are known to provoke or aggravate psoriasis (e.g. ß-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding the treatment phase of the trial and during the trial;
- •treatment with vitamin A supplements;
- •treatment with any biologics within 3 months preceding the treatment phase of the trial and during the trial, or in the case of ustekinumab, within 6 months;
- •treatment with any immunosuppressive medication within 6 months preceding the treatment phase of the trial and during the trial;
- •known allergic reactions, irritations or hypersensitivity to the active ingredients (BX, BDP or calcipotriol) or any other ingredient of the IMPs;
- •contraindications according to summary of product characteristics (SmPC) of the active comparator:
- •-hypersensitivity against the substance or to any of the excipients;
- •-erythrodermic, exfoliative and pustular psoriasis
- •-virus-induced skin lesions (e.g. herpes, varicella)
- •-known calcium metabolism disorders;
- •-viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections;
- •-skin manifestations in relation to tuberculosis or syphilis;
- •-perioral dermatitis;
- •-atrophic skin, striae atrophicae;
- •-fragility of skin veins;
- •-ichthyosis;
- •-acne vulgaris;
- •-perianal and genital pruritus.
- •concomitant use of ketoconazole, itraconazole, erythromycin, grapefruit juice or gemfibrozil or application of products that contain DEET (N,N-diethyl-m-toluamide);
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •symptoms of a clinically significant illness that may influence the outcome of the trial in the 4 weeks before first treatment and during the trial;
- •vaccination within the 6 days prior to the trial;
- •history of malignancy of any organ system (less than 5 years ago);
- •participation in the treatment phase of another clinical trial within the last 4 weeks prior to the first administration of IMPs in this clinical trial or during the trial;
- •in the opinion of the investigator or physician performing the initial examination the patient should not participate in the trial, e.g. due to probable noncompliance or inability to understand the trial and give adequately informed consent;
- •close affiliation with the investigator (e.g. a close relative) or persons working at bioskin GmbH, the other sites or for the sponsor;
- •patient is institutionalized because of legal or regulatory order.
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