EUCTR2015-004899-30-Outside-EU/EEA进行中（未招募）1 期
Multi-center, Randomised, Double-blind, Parallel, Placebo Controlled Study Of 0.05% Clobetasone Butyrate Cream in Subjects with Eczema to evaluate the Efficacy and Safety.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •- Subjects with a diagnosis of eczema, fulfil the 3 follow items:
- •1) Erythema, papilla/water blister, Lichenification, skin damage with infiltration,
- •2) unknown reason, recurrent attacks;
- •3) itching in diseased skin
- •- Subjects must have body surface area (BSA) disease involvement of less than or equal to 10% as assessed by palm method
- •- Subject must present with moderate and above eczema as defined by a score greater than or equal to 3 using the investigators global assessment (IGA) of eczema severity.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- The subject presents with any systemic disorder or active skin disease (e.g. psoriasis) that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening.
- •- The subject has eczema restricted to the face, the feet or the hands only.
- •- The subject is indicated any anti-infectives drug for a current complication of overt bacterial, fungal and viral infection
- •- History of recent (<1 month) active or presence of current superficial skin infections of viral aetiology such as herpes simplex, or varicella.
- •- The subject has been exposed to below therapy within the set timeframe: Topical agents administered in the diseased skin, including emollient - 1 week; Systemic administration of anti-histamine agents - 2 week; Systemic administration of corticosteroid -4 week; Systemic administration of immunosuppressive drugs - 4 week; UV therapy -4 week
- •- Foreseeable intensive ultraviolet (UV) exposure during the study (solar or artificial). Subjects must not be exposed to intense direct sunlight for long periods, and must not use skin tanning devices (e.g. sunbed) for the duration of the study.
- •- History of clinically significant cardiovascular, pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities.
- •- History of allergy to components of test medications to be used in the study.
- •- History of anaphylaxis (a sudden, potentially life-threatening systemic allergic reaction) to food, medications, insect venom, or latex.
研究者
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