Elocon vs Fluticasone in Localized Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 245
- 主要终点
- Clinical evaluation of the change in disease status which would be defined as improvement by Day 8 relative to their severity at entry in treated areas.
研究概览
简要总结
This is an open-label, randomized, parallel-group clinical study. The primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the management of Indian patients with localized psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •>=18 years of age
- •Written informed consent
- •Having localized psoriasis (not more than 5-6 patches)
- •Total size of all patches should be below 8" x 8"
- •Each patient should exhibit any of the following 4 signs of dermatoses:
- •palpability
- •itching (pruritus)
- •Each of the above signs would be grades according to the following scale:
- •= severe The total Disease Severity Score (ie, the sum of the scores for each of the signs) should be at least 6 (indicative of a moderate to severe disease status)
排除标准
- •Pregnancy or lactation
- •Hypersensitivity to any of the components of the test medication
- •Signs of atrophy in the target area
- •Lesions on palms, soles, and scalp
- •Individuals who may require medications that might affect the natural course of the disease
- •Not having used systemic corticosteroids or antimetabolites or any other topical corticosteroid within 2 weeks prior to enrollment in the study
- •Concomitant tuberculosis/viral infection
研究组 & 干预措施
Arm 1
干预措施: Mometasone (Drug)
Arm 2
干预措施: Fluticasone (Drug)
结局指标
主要结局
Clinical evaluation of the change in disease status which would be defined as improvement by Day 8 relative to their severity at entry in treated areas.
时间窗: Day 8
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 4.
时间窗: Day 4
Clinical evaluation of the change in disease status which would be defined as improvement by Day 4 relative to their severity at entry in treated areas.
时间窗: Day 4
Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 8.
时间窗: Day 8
次要结局
- Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 15.(Day 15)
- Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 29.(Day 29)
- Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 22.(Day 22)
- Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 29.(Day 29)
- Reduction in mean symptom scores for erythema, induration, pruritus, and scaling on Day 22.(Day 22)
- Clinical evaluation of the change in treated areas relative to their severity at entry would also be evaluated on Day 15.(Day 15)