A Study to Investigate the Irritation Potential on Healthy Intact Skin and Effect on Psoriatic Skin of Topical Applications of GW786034
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Visual assessment and clinical scoring of lesion treatment areas using modified Psoriasis Area Scoring Index (PASI) target lesion assessment scale Clinical lab tests vital signs adverse events clinical monitoring/observation
研究概览
简要总结
This study is an exploratory study to evaluate the effectiveness, safety and tolerability of three concentrations of GW786034 ointment following treatment to small areas of stable psoriatic plaques. Dosing will proceed using a microplaque approach, where small volumes of ointment will be applied under full occlusion to representative psoriatic plaques. The effectiveness of topical GW786034 treatments and controls will be explored using visual intensity assessments in addition to dermal imaging and histological surrogates of disease activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（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
Subjects receiving treatment A
Eligible subjects will receive 0.1 percent pazopanib ointment.
干预措施: Pazopanib (Drug)
Subjects receiving treatment B
Eligible subjects will receive 0.5 percent pazopanib ointment.
干预措施: Pazopanib (Drug)
Subjects receiving treatment C
Eligible subjects will receive 1 percent pazopanib ointment.
干预措施: Pazopanib (Drug)
Subjects receiving treatment D
Eligible subjects will receive pazopanib vehicle as negative control.
干预措施: Pazopanib vehicle (Drug)
Subjects receiving treatment E
Eligible subjects will receive 0.1 percent betamethasone valerate ointment as steroid positive control.
干预措施: Betamethasone valerate (Drug)
Subjects receiving treatment F
Eligible subjects will receive 0.005 percent calcipotriol ointment as vitamin D agonist positive control.
干预措施: Calcipotriol (Drug)
结局指标
主要结局
Visual assessment and clinical scoring of lesion treatment areas using modified Psoriasis Area Scoring Index (PASI) target lesion assessment scale Clinical lab tests vital signs adverse events clinical monitoring/observation
时间窗: Up to 8 weeks
次要结局
- Laser doppler imaging,epidermal thickness by histology skin biopsies Primary pharmacokinetic endpoints AUC(0-t) and Cmax of GW786034 in plasma following repeat dosing(Up to 8 weeks)