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临床试验/NCT00733954
NCT00733954已完成4 期

A Comparison Between Clobetasol Propionate (Clobex®) Spray and Clobetasol Propionate Ointment With Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Plaque Psoriasis

Galderma R&D6 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2007年8月最近更新:
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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
250
试验地点
6
主要终点
Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a comparison between Clobetasol Propionate Spray and Clobetasol Propionate Ointment with Regard to Efficacy, Safety, Subject Satisfaction and Duration of Response in Moderate to Severe Stable Plaque Psoriasis. Subjects will be enrolled and randomized into one of two groups: clobetasol propionate Spray for 4 weeks of treatment or clobetasol propionate ointment for 2 weeks of treatment with a 2 week follow-up visit for each group.

详细描述

Same as above.

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 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Subjects with a diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% of the body surface area. For the purposes of study treatment, most areas will be treated with the exception of face, scalp, groin, axillae and other intertriginous areas
  • •Overall disease severity is at least 3 (moderate)

排除标准

  • •Subjects who have surface area involvement too large that would require more than 50 grams per week of clobetasol propionate spray or more than 50 grams per week of clobetasol propionate ointment
  • •Subjects whose psoriasis involves only the scalp, face or groin
  • •Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis

研究组 & 干预措施

clobetasol propionate spray

Active Comparator

clobetasol propionate spray 0.05%

干预措施: clobetasol propionate spray (Drug)

clobetasol propionate ointment

Active Comparator

clobetasol propionate ointment 0.05%

干预措施: clobetasol propionate ointment (Drug)

结局指标

主要结局

Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to End of Treatment Based on the Overall Disease Severity (ODS) Scale

时间窗: Baseline and Week 2 and Baseline and Week 4

Success Rate on Overall Disease Severity (ODS) scale (Clear/Almost Clear, Mild, Moderate, Severe/Very Severe with Clear/Almost Clear being best and Severe/Very Severe being worst) from Baseline to End of Treatment (wk 4 - clobetasol propionate spray; wk 2 - clobetasol propionate ointment)

次要结局

  • Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to After Two Weeks of Treatment Based on the Overall Disease Severity (ODS) Scale(Baseline and Week 2)
  • Number of Participants Who Are Clear/Almost Clear of Plaque Psoriasis From Baseline to 2 Weeks Post Treatment Based on the Overall Disease Severity (ODS) Scale(Baseline and Week 4 and Baseline and Week 6)
  • Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to After Two Weeks of Treatment(Baseline and Week 2)
  • Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to After Two Weeks of Treatment(Baseline and Week 2)
  • Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to End of Treatment(Baseline and Week 2 and Baseline and Week 4)
  • Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to End of Treatment(Baseline and Week 2 and Baseline and Week 4)
  • Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to Two Weeks Post Treatment(Baseline and Week 4 and Baseline and Week 6)
  • Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to After Two Weeks of Treatment(Baseline and Week 2)
  • Number of Participants With Decrease in Signs of Psoriasis (Scaling) From Baseline to End of Treatment(Baseline and Week 2 and Baseline and Week 4)
  • Number of Participants With Decrease in Signs of Psoriasis (Erythema) From Baseline to Two Weeks Post Treatment(Baseline and Week 4 and Baseline and Week 6)
  • Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to After Two Weeks of Treatment(Baseline and Week 2)
  • Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to End of Treatment(Baseline and Week 2 and Baseline and Week 4)
  • Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to Two Weeks Post Treatment(Baseline and Week 4 and Baseline and Week 6)
  • Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) From Baseline to Two Weeks Post Treatment(Baseline and Week 4 and Baseline and Week 6)
  • Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to After Two Weeks of Treatment(Baseline and Week 2)
  • Percent Decrease in Body Surface Area Affected (%BSA Affected) From Baseline to End of Treatment(Baseline and Week 2 and Baseline and Week 4)
  • Percent Decrease in Body Surface Area Treated (%BSA Treated) From Baseline to Two Weeks Post Treatment(Baseline and Week 4 and Baseline and Week 6)
  • Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Two Weeks Post Treatment(Baseline and Week 4 and Baseline and Week 6)

研究者

发起方
Galderma R&D
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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