A Multi-Center, Open-Label Study to Evaluate the Safety and Efficacy of a Consecutive Treatment Regimen of Clobetasol Propionate 0.05% Spray, Followed by Calcitriol Ointment 3µg/g, in the Management of Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 305
- 试验地点
- 12
- 主要终点
- Overall Disease Severity Success (ODS)
研究概览
简要总结
The primary objectives of this study are to evaluate the safety & efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.
详细描述
Same as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
- •Overall Disease Severity of at least 3 (moderate)
排除标准
- •Surface area involvement too large (>20% BSA)
- •Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas
研究组 & 干预措施
Study Treatment
clobetasol propionate spray 0.05%
Other Names:
Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily
calcitriol ointment
Other Names:
Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
干预措施: clobetasol propionate spray 0.05% (Drug)
Study Treatment
clobetasol propionate spray 0.05%
Other Names:
Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily
calcitriol ointment
Other Names:
Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
干预措施: calcitriol ointment (Drug)
结局指标
主要结局
Overall Disease Severity Success (ODS)
时间窗: 8 and 12 weeks
Success was defined as a one-grade improvement in ODS from baseline.
次要结局
- Signs of Psoriasis - Erythema(2, 4, 8 and 12 weeks)
- Percent Change From Baseline in Body Surface Area (% BSA) Affected(2, 4, 8 and 12 weeks)
- Overall Disease Severity(2, 4, 8 and 12 weeks)
- Signs of Psoriasis - Scaling(2, 4, 8 and 12 weeks)
- Tolerability Assessment - Pruritus(Baseline, 2, 4, 8 and 12 weeks)
- Global Improvement Score(2, 4, 8 and 12 weeks)
- Tolerability Assessment - Telangiectasias(Baseline, 2, 4, 8 and 12 weeks)
- Tolerability Assessment - Stinging/ Burning(Baseline, 2, 4, 8 and 12 weeks)
- Tolerability Assessment - Folliculitis(Baseline, 2, 4, 8 and 12 weeks)
- Signs of Psoriasis - Plaque Elevation(2, 4, 8 and 12 weeks)
- Tolerability Assessment - Skin Atrophy(Baseline, 2, 4, 8 and 12 weeks)