Phase 4 Open-Label Multicenter Community-based 4-Wk Trial to Assess Efficacy, Tolerance to Tx & Patient Satisfaction w/ CLOBEX® Spray When Used as Mono- or Add-on Therapy to Existing Systemic/Topical Agents for Tx of Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 2,488
- 试验地点
- 1
- 主要终点
- Efficacy - Change in Target Plaque Severity rating
研究概览
简要总结
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents.
详细描述
Evaluation of the effectiveness of Clobex® Spray, 0.05% when used as monotherapy or add-on therapy to existing systemic or topical anti-psoriatic agents, as determined by the change in the target plaque severity (TPS) rating between Weeks 0 and 4.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Moderate to severe plaque psoriasis between 3% and 20% of Body Surface Area (BSA) with a target plaque severity (TPS) of moderate to severe
- •At least 1 target site (not on the palms or soles of the feet) with a TPS rating of moderate to severe and with 1 or more elevated, easily palpable, plaques having well-circumscribed margins, and at least 1 cm in diameter
- •History of stable plaque psoriasis of greater than or equal to 3 months
排除标准
- •Diagnosis of guttate, generalized pustular, erythrodermic, psoriatic arthritis, or nail psoriasis as the sole or predominant form of psoriasis
- •Psoriatic arthritis that was not stable or might have required a change in medication during the 4-week study period
- •Plaque psoriasis requiring treatment on the face, scalp, neck, groin, and armpits
研究组 & 干预措施
1
Monotherapy - Subjects who are not currently being treated with anti-psoriatic medication and start using Clobex®
干预措施: Clobetasol Propionate, 0.05% (Drug)
2
Add-on therapy - Subjects who are taking some form of anti-psoriatic medication and add Clobex® treatment
干预措施: Clobetasol propionate, 0.05% Spray (Drug)
结局指标
主要结局
Efficacy - Change in Target Plaque Severity rating
时间窗: 4 weeks
次要结局
- Safety - Evaluation of adverse events and tolerability(4 weeks)
- Efficacy - Self-Assessment of Quality of Life, Subject satisfaction(4 weeks)