jRCT2080224538已完成3 期
Efficacy and safety of LEO 90100 foam in Japanese subjects with psoriasis vulgaris
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- overall improvement rate
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Phase 3, National, Multi-centre, 4-week, Prospective, Randomised, Controlled, Parallel-group,open Trial Of Leo 90100 Foam Versus Dovobet Ointment In Japanese Subjects With Psoriasis Vulgaris.
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Japanese subjects aged 20 years or more
- •2.Clinical diagnosis of psoriasis vulgaris of less than or equal to 30% BSA (excluding any psoriasis on the face, skin folds, genitals)
- •3.A target psoriasis lesion on the body, of a minimum size of 10 cm2 and scoring at least 2 (mild) for each of redness, thickness and scaliness
- •4.Females of childbearing potential must have a negative result for a urine pregnancy test at Day 1 (Visit 1) and must agree to use an adequate method of birth control
排除标准
- •Use of systemic treatment with an effect on psoriaisis
- •Use of UV therapy on full body or on the target lesion
- •Use of topical treatment on areas to be treated with trial medication
- •Topical treatment on areas other than treated areas with vitamin D
- •analogues, immunosuppressants or strong/very strong corticosteroids
- •Skin diseases besides psoriasis on the areas to be treated with trial medication.
- •Disorders of calcium metabolism, hypercalcaemia, renal insufficiency, hepatic disorders, heart disease.
结局指标
主要结局
overall improvement rate
时间窗: Visit 4 (end of Week 4)
The primary endpoint is "overall improvement rate" for the target lesion at Visit 4 (end of Week 4), defined as "substantial resolution" of clinical signs or at least "moderately improved" in the general change in the target lesion. "Substantial resolution" is defined as a clinical score for thickness and scaliness of 0 and a clinical score for redness of 1 or less in the severity of clinical signs of the target lesion.
次要结局
- overall improvement rate(Visits 2 and 3 (end of Weeks 1 and 2))
- change in total sign score(Visit 1 to Visit 4)
- change in sum of scores for severity(Visit 1 to Visit 4 (end of Week 4))
- number of adverse events
研究者
研究点 (1)
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