EUCTR2007-007037-39-DE进行中（未招募）不适用
A Phase II Proof-of-Concept, Randomized, Double-blind, Vehicle-controlled Study, Including an Open-label Comparison to an Active Control, To Assess the Efficacy and Safety/Tolerability of Topical Riluzole in Patients with Stable Plaque-type Psoriasis - BF-37 in stable plaque-type psoriasis
相关药物
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
- •Ability to understand the nature of the study and the study-related procedures;
- •Willingness and ability to sign the Informed Consent Form and comply with any study-relevant regulations;
- •At least 18 years of age;
- •Stable plaque-type psoriasis with plaques of at least 2 cm in diameter at five comparable treatment areas, which are separated from each other by at least 2 cm for occluded and by at least 5 cm for non-occluded treatment areas;
- •Symptom sum score of at least 6 for each treatment area, i.e. a minimum score of 2 for each of the three clinical symptoms erythema, induration and scaling;
- •Stable general health condition in discretion of the investigator.
- •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
- •Known allergy or hypersensitivity to the active pharmaceutical ingredient riluzole, to any of the excipients used in the vehicle or to the active pharmaceutical ingredient and/or excipients used in the positive control Betnesol®-V cream 0.1%;
- •Liver disease or transaminase values > 2 times upper normal limit (UNL);
- •Total bilirubin above the upper normal limit;
- •Renal impairment, characterized by a glomerular filtration rate (GFR) < 60 ml/min (calculated by using the modification of diet in renal disease (MDRD) formula.
研究者
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