NCT03827876招募中4 期
An Open-Label Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Etanercept or Adalimumab
Psoriasis Treatment Center of Central New Jersey1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PGA x BSA improvement
研究概览
简要总结
4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10% BSA who are receiving etanercept or adalimumab for at least 24 weeks
详细描述
30 subjects treated with etanercept or adalimumab for at least 24 weeks with a body surface area 2-10% and physician global assessment greater than or equal to 2 will receive Enstilar® once daily for 4 weeks followed by QOD for 12 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult ≥ 18 years of age;
- •Diagnosis of chronic plaque-type
- •Patient with 2-10% BSA
- •Physician Global Assessment of 2 or greater
- •Patient has been treated with etanercept or adalimumab for a minimum of 24 weeks
排除标准
- •˂2 or >10% BSA
- •Patient not receiving etanercept or adalimumab, or receiving etanercept or adalimumab <24weeks
研究组 & 干预措施
Open Label Enstilar
Experimental
once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira
干预措施: Enstilar 0.005%-0.064% Topical Foam (Drug)
结局指标
主要结局
PGA x BSA improvement
时间窗: 16 weeks
body surface area multiplied by physician global assessment
次要结局
- Itch Numerical Rating Scale(16 weeks)
- BSA improvement(16 weeks)
- Dermatology Life Quality Index improvement(16 weeks)
研究者
研究点 (1)
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