NCT01893567已完成4 期
Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Subject Reported Target Lesion Severity Score.
研究概览
简要总结
The aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with Clobex spray treatment.
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
- •Subjects 18 years of age or older.
- •Subjects with a board certified dermatologist clinical diagnosis of active moderate to severe psoriasis lesions affecting up to 20% of the body surface area at the baseline visit, and in the opinion of the investigator, is otherwise a good candidate for treatment with clobetasol propionate 0.05% spray.
- •Subjects with a target lesion of at least 1 cm x 1 cm
- •Subjects who agree to be photographed at each visit
排除标准
- •Subjects with any condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study.
- •Subjects with any known allergies to any of the ingredients listed on the test article label or surgical ink.
- •Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast feed during the course of the trial.
- •Subjects that are relatives of the investigator, or are themselves or a relative of any study staff or any Galderma employee.
- •Subjects who have participated in an investigational study within 30 days of enrollment; participated in biologic investigational studies within 90 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.
研究组 & 干预措施
Clobex spray
Experimental
干预措施: Clobex Spray (Drug)
结局指标
主要结局
Subject Reported Target Lesion Severity Score.
时间窗: 2 weeks
Subject reported mean scores of the target lesion numeric rating scale (TL-NRS; scale of 0 (no psoriasis) to 10 (very severe psoriasis)) at end of study.
次要结局
- Investigator Reported Target Lesion Severity Score(2 weeks)
研究者
研究点 (1)
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