EUCTR2005-004859-35-DE进行中（未招募）不适用
Determination of antipsoriatic efficacy of topical formulations and comparison to a brand medication and placebo in a psoriasis plaque test
G&W Laboratories, Inc.0 个研究点目标入组 15 人开始时间: 2006年3月7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
- 15
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 subjects aged 18 to 64 years;
- •subjects with psoriasis vulgaris in a chronic stable phase and stable plaques with an area sufficient for six treatment fields;
- •the physical examination must be without disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study;
- •sexually active females of childbearing potential should use a medically accepted contraceptive regimen: surgically sterile (hysterectomy or tubal ligation), systemic contraceptive (oral, implant, injection), diaphragm with intravaginal spermicide, cervical cap with intravaginal spermicide, intrauterine device (IUD), condom with intravaginal spermicide;
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •subjects who require systemically acting medications for the treatment of psoriasis which might counter or influence the study objectives, e.g. corticosteroids, cytostatics;
- •local treatment with antipsoriatics (except for salicylic acid in vaseline) in the 4 weeks preceding and during the study (corticosteroids 8 weeks);
- •systemic treatment with antipsoriatics in the three months preceding and during the study;
- •treatment with systemic or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids, MAO inhibitors, anti-epileptic drugs, anti-psychotic drugs) or medications which are known to provoke or aggravate psoriasis, e.g. b-blocker, antimalarial drugs within two weeks before the beginning of the study and during the study;
- •known allergic reactions to the active ingredients or other components of the study preparations, comparators or control;
- •patients with demonstrated hypercalcemia or evidence of vitamin D toxicity;
- •evidence of drug abuse;
- •pregnancy or nursing;
- •UV-therapy within four weeks before beginning and during the study;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •participation in another clinical trial involving pharmaceutical products in the four weeks preceding and during the study;
- •in the opinion of the investigator or physician performing the initial examination the subject should not participate in the study, e. g. due to probable noncompliance or inability to understand the study and give adequately informed consent.
研究者
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