EUCTR2009-009379-36-DE进行中（未招募）不适用
A phase II, single-center, randomized, controlled, observer-blind study with intra-individual comparisons within two parallel groups to assess the efficacy of a topical Aescin formulation in the treatment of allergic contact dermatitis
Marinomed Biotechnologie GmbH0 个研究点目标入组 40 人开始时间: 2009年2月26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
- 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
- •All of the following criteria have to be met for inclusion of a subject in the study:
- •men and women aged 18 years or older;
- •known nickel allergy (confirmed in a respective test performed by an allergologist,
- •allergic reactions against nickel within the last five years;
- •healthy skin on which reddening can be easily recognized in the area of the test
- •the physical examination must be without disease findings unless the investigator
- •considers an abnormality to be irrelevant to the outcome of the study;
- •female volunteers of childbearing potential must either 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are to be excluded from the study when one or more of the following conditions are met:
- •acne, suntan, eczema, visible infections, hyperpigmentation or tattoos in the test
- •UV-therapy within 4 weeks before study day 1 and during the study;
- •dark-skinned persons whose skin color prevents ready assessment of skin
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •symptoms of a clinically significant illness that may influence the outcome of the
- •study in the four weeks before and during the study (e.g. psoriasis);
- •participation in the treatment phase of another clinical study within the last four
- •weeks prior to the first administration of investigational drug in this study;
- •known allergic reactions to components of the study preparations (e.g. cetylstearyl
- •alcohol and benzyl alcohol);
- •treatment with systemic or locally acting medications which might counter or
- •influence the study aim within two weeks before the beginning of the study (e.g.
- •antihistamines, glucocorticosteroids, acetylsalicylic acid or cromoglycates);
- •contraindications according to summary of product characteristics:
- •- known hypersensitivity against one of the components (for Flogencyl: ß-aescin
- •and for Linolacort Hydro 1.0 %: hydrocortisone);
- •- specific skin process or skin diseases (e.g. skin tuberculosis, herpes, varicella);
- •- skin reactions after vaccination;
- •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;
- •planned surgical procedure within the time frame of the study;
- •subject is institutionalized because of legal or regulatory order.
研究者
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