EUCTR2006-006653-27-DE进行中（未招募）不适用
Phase IIa, single-center, randomized, double-blind, vehicle-controlled study to determine the efficacy and safety/tolerability of a topical riluzole formulation in patients with atopic eczema - Atopic eczema
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
- •All of the following criteria have to be met for inclusion of a volunteer in the study:
- •signed written informed consent obtained;
- •male or female subjects, 18 to 64 years;
- •manifest atopic dermatitis diagnosed according to Hanifin and Rajka (3);
- •two comparable lesional areas of 20 - 50 cm2 with a distance of at least 5 cm, clinical condition of atopic eczema mild to moderate;
- •TEWL in the lesional areas at least 12 g/m²h, TEWL value differences = 30 % are allowed between both lesional areas;
- •the physical examination must be without further disease findings unless the investigator considers an abnormality to be clinically irrelevant;
- •sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective medically accepted contraceptive regimen: systemic contraceptive (combined oral contraceptive, implant, injection), safe intrauterine device (IUD).
- •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 are to be excluded from the study when one or more of the following conditions are met:
- •acne, suntan, eczema other than Atopic eczema, hyper- or hypopigmentation or tattoos in the treatment areas;
- •dark-skinned persons whose skin color prevents ready assessment of skin reactions;
- •evidence of drug or alcohol abuse;
- •pregnancy or nursing;
- •UV-therapy within 6 weeks before first treatment;
- •participation in another clinical study involving pharmaceutical products in the 28 days preceding or during the study;
- •symptoms of a clinically significant illness that may influence the outcome of the study in the month before and during the study;
- •known allergic reactions to components of the study preparations;
- •liver disease or transaminase values > 3 times upper normal limit;
- •kidney insufficieny;
- •neutropenia;
- •systemic treatment or locally acting medications which might counter or influence the study aim (e.g. glucocorticosteroids or medication that influences liver function) within four weeks before first study treatment (exception: asthma may be found in subjects with atopic dermatitis, therefore inhalation with corticosteroids in subjects with asthma accompanying atopic dermatitis will be allowed at a dose not exceeding 1 mg/day. The dosage should remain constant throughout the study period);
- •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;
- •subject is institutionalized because of legal or regulatory order.
研究者
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