EUCTR2011-003807-39-DE进行中（未招募）不适用
A phase II, single-center, randomized, observer-blind, vehicle-controlled trial to determine clinical equivalence of MomeGalen Cream (mometasone furoate 0.1 %) to Ecural® Fettcreme (reference drug) and superiority to the active ingredient-free vehicle by evaluation of the anti-psoriatic efficacy in a psoriasis plaque test
GALENpharma0 个研究点目标入组 30 人开始时间: 2011年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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 and women aged 18 to 75;
- •subjects with psoriasis vulgaris in a chronic stable phase;
- •subjects with stable plaques with an area sufficient for three treatment fields; the target lesion(s) should be on the trunk or extremities (excluding palms/soles); psoriatic lesion on the knees or elbows cannot be used as a target lesion;
- •the infiltrate thickness in the target lesion has to be greater than 200 µm;
- •the physical examination of the skin must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the clinical trial;
- •female volunteers of childbearing potential had either to be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices [IUDs], sexual abstinence or vasectomized partner;
- •written informed consent obtained
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis;
- •local treatment with antipsoriatics (like vitamine D, dithranol, glucocorticosteroids; except for salicylic acid in vaseline) in the 4 weeks preceding and/or during the trial; and any topical antipsoriatic treatment on the plaques to be treated in this trial (including corticosteroids, except for salicylic acid) in the 8 weeks before first treatment and/or during the trial;
- •systemic treatment with antipsoriatics e.g. corticosteroids, cytostatics in the three months before first treatment and during the trial;
- •treatment with systemic or locally acting medications which might have countered or influenced the trial aim (medications which are known to provoke or aggravate psoriasis, e.g. ?-blocker, antimalarial drugs, lithium) within eight weeks before first treatment and/or during the trial;
- •known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products;
- •contraindications according to summary of product characteristics of Ecural® Fettcreme;
- •known non-responders to reference listed drug Ecural® Fettcreme;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •UV-therapy within four weeks before first treatment and during the trial;
- •symptoms of a clinically significant illness that may influence the outcome of the trial in the four weeks before first treatment and during the trial;
- •participation in the treatment phase of another clinical trial within the last four weeks prior to first treatment in this clinical trial;
- •in the opinion of the investigator or physician performing the initial examination the subject should not have participated 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 or subject is an employee of sponsor;
- •subject was institutionalized because of legal or regulatory order
研究者
相似试验
进行中（未招募）
不适用
A phase IIa, single-center, randomized, observer-blind, placebo- and reference-controlled proof of concept study with intraindividual comparison of treatments to investigate the safety and antipsoriatic efficacy of topical valrubicin formulations in a psoriasis plaque test - Efficacy and tolerability of varubicin cream in concentrations of 0.5 % and 1 % in a PPTEUCTR2009-017692-18-DEValderm ApS
进行中（未招募）
不适用
A phase IIa, single-center, randomized, observer-blind trial with intraindividual comparison of treated versus untreated to assess the wound healing efficacy of topical Tyrosur® Gel after experimental impairment of the skin using an abrasive wound healing modelEUCTR2010-020809-33-DEEngelhard Arzneimittel GmbH & Co.KG
进行中（未招募）
不适用
A phase II, randomized, multicentre, observer-blind study to compare and characterize the immunoginicity and safety parameters induced by various GSK Biologicals’ Adjuvant Systems in combination with the Hepatitis B surface antigen (HBsAg), according to a 0, 1 month schedule with a booster at Month 12, in healthy, Hepatitis B virus (HBV) naïve, adults. - EARLY-CLINRES-002EUCTR2008-004455-29-BEGlaxoSmithKline Biologicals710
进行中（未招募）
不适用
A phase II, randomized, multicentre, observer-blind study to compare and characterize the immunoginicity and safety parameters induced by various GSK Biologicals’ Adjuvant Systems in combination with the Hepatitis B surface antigen (HBsAg), according to a 0, 1 month schedule with a booster at Month 12, in healthy, Hepatitis B virus (HBV) naïve, adults. - EARLY-CLINRES-002Hepatitis B surface antigen (HBsAg) vaccine administred in HBV naïve adult subjects aged between 18 and 45 years old, inclusive, in good general health.EUCTR2008-004455-29-DEGlaxoSmithKline Biologicals710
进行中（未招募）
不适用
A study to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.Influenza, human.EUCTR2015-000176-10-Outside-EU/EEACSL Limited450