A Phase IIa, 28-day Treatment, Multi-center, Randomized, Comparator-controlled, Observer-blind Trial With Intra-individual Left/Right Comparison to Investigate the Anti-psoriatic Efficacy and the Safety of an LAS41004 Formulation in Comparison to an Active Reference in Patients With Mild to Moderate Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total symptom score
研究概览
简要总结
Proof-of concept study to competitively investigate antipsoriatic efficacy and safety of a LAS41004 formulation vs active control No formal study hypothesis, but descriptive evaluation (PoC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LAS41004
Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily
干预措施: LAS41004 (Drug)
LAS41004
Topical application of approximately 2 - 6 mg/cm2 to an area of 20 - 300 cm2, each once daily
干预措施: control (Drug)
control
Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily
干预措施: LAS41004 (Drug)
control
Topical application of approximately 2 - 6 mg/cm2 of IMPs 1 and 2 to an area of 20 - 300 cm2, each once daily
干预措施: control (Drug)
结局指标
主要结局
Total symptom score
时间窗: day 28 vs baseline
The primary variable is the TSS. The TSS is calculated by summarizing the individual scores for erythema, scaling and infiltration
次要结局
- Total symtom score (during study performance)(Days 4, 8, 15, and 22)
- Physician's global assessment (PGA)(Days 1, 4, 8, 15, 22 and 29)
- Physician's global tolerability assessment (PGTA)(4, 8, 15, 22 and 29)