A 28-day, Double-blind, Randomized, Reference-controlled Psoriasis Plaque Test to Evaluate the Efficacy and Safety of Two Different BAY1003803 Formulation Types in 2 Concentrations Each in Treatment of Symptomatic Volunteers With Plaque-type Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 23
- 主要终点
- Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound
研究概览
简要总结
To explore the efficacy and safety of four BAY1003803 formulations by means of a within subject comparison in an open Psoriasis Plaque Test
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female (non-childbearing potential) volunteer with stable plaque-type psoriasis, but otherwise healthy
- •Age: 18-64 years
排除标准
- •Severe disease within the last 4 weeks prior to the first study drug administration as determined by the investigator
- •Any topical antipsoriatics on plaques potentially to be treated in this trial (including corticosteroids, vitamin D analogues, immunomodulators, retinoids, dithranol and tar, except for salicylic acid (Pretreatment) in the 4 weeks before first treatment and/or planned during the trial, except for allowed topical treatment on the face, ears and scalp
- •Systemic treatment depending on kind of treatment within 4 weeks and 6 months prior and/or planned during the trial
- •Treatment with concomitant medication that may affect and provoke or aggravate psoriasis, e.g. antimalarial drugs, lithium, beta-blockers or angiotensin-converting-enzyme inhibitors (AEC inhibitors) unless on a stable dose for 3 months before study medication initiation
- •Clinico-chemical parameters of clinically significant deviation
研究组 & 干预措施
BAY1003803 0.1% lipophilic cream
BAY1003803 0.1% lipophilic cream (on plaque and healthy skin)
干预措施: BAY1003803 (Drug)
BAY1003803 0.1% ointment
BAY1003803 0.1% ointment (on plaque and healthy skin)
干预措施: BAY1003803 (Drug)
BAY1003803 0.01% lipophilic cream
BAY1003803 0.01% lipophilic cream (on plaque and healthy skin)
干预措施: BAY1003803 (Drug)
BAY1003803 0.01% ointment
BAY1003803 0.01% ointment (on plaque and healthy skin)
干预措施: BAY1003803 (Drug)
Clobetasol propionate
Clobetasol propionate ointment 0.05 % (on plaque and healthy skin)
干预措施: Clobetasol propionate (Drug)
Betamethasone/calcipotriene
Betamethasone/calcipotriene ointment 0.05 %/0.005% (on healthy skin)
干预措施: Betamethasone/calcipotriene (Drug)
结局指标
主要结局
Change in infiltrate thickness from day 1 to day 29 measured by sonography using 22 MHz B mode ultrasound
时间窗: Day 1 to 29
次要结局
未报告次要终点