A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
研究概览
简要总结
The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
详细描述
This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.
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
- Single (Investigator)
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
- •Body surface area (BSA) affected with psoriasis between 4% and 20% .
- •Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on the Psoriasis Grading Scale for Target Lesion.
- •Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or moderate (2 or 3).
- •Definitive diagnosis of elbow and/or knee plaque-type psoriasis.
- •Capable of understanding and willing to provide a signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures were performed.
- •Male or female, 18 years of age or older at the time that the consent form was signed.
- •Able to complete the study and comply with study instructions.
- •Female subjects of childbearing potential must have had a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception.
排除标准
- •Use of any emollient applied to psoriasis plaques treated with the study medication during the study.
- •Other serious skin disorder or any chronic medical condition that is not well controlled.
- •Female subjects who are pregnant, trying to become pregnant or lactating.
- •Any major illness within 30 days prior to the baseline visit.
- •Received any investigational drug or treatment within 30 days of the baseline visit or who are scheduled to receive an investigational drug or treatment other than the study products during the study.
研究组 & 干预措施
Olux-E Foam
Olux-E (clobetasol propionate 0.05%) foam
干预措施: Olux-E Foam (Drug)
Clobex lotion
Clobex (clobetasol propionate 0.05%) lotion.
干预措施: Clobex lotion (Drug)
结局指标
主要结局
At Least a One Grade Improvement for the Target Psoriasis Lesion on the Elbow or Knee (Psoriasis Grading Scale)
时间窗: Baseline to day 15
Number of participants who achieved a minimum 1-grade improvement in elbow and/or knee lesion using the Psoriasis Grading Scale for Target Lesion Score: 0 = No evidence of scaling, erythema, or elevation. 1 = Minimal; occasional scale, faint erythema, slight elevation. 2 = Mild; fine scales, light red color, slight elevation. 3 = Moderate; coarse scales, moderate red coloration and elevation . 4 = Marked; thick scale, bright red coloration, marked elevation. 5 = Severe; very thick tenacious scale predominates, dusky to deep red coloration, very marked elevation.
次要结局
- At Least 1 Grade Improvement Psoriasis Grading Scale(Baseline, days 3 and 8)
- At Least a 2 Grade Improvement Psoriasis Grading Scale(Baseline, days 3, 8, 15)
- At Least a 3 Grade Improvement Psoriasis Grading Scale(Baseline, days 3, 8, 15)
- At Least 1 Grade Improvement in the Psoriasis Global Assessment(Baseline, days 3, 8, 15)
- At Least a 2 Grade Improvement in the Psoriasis Global Assessment(Baseline, days 3, 8, 15)
- At Least a 3 Grade Improvement in the Psoriasis Global Assessment(Baseline, days 3, 8, 15)
- At Least 1 Grade Improvement in Subject's Global Assessment(Baseline, days 3, 8, 15)
- At Least a 2 Grade Improvement in Subject's Global Assessment(Baseline, days 3, 8, 15)
- At Least a 3 Grade Improvement in Subject's Global Assessment(Baseline, days 3, 8, 15)
- Median Change in Psoriasis Grading Scale(Baseline, Days 3, 8, 15)
- Dermatology Quality of Life - Symptoms and Feelings(Baseline, Days 3, 8, 15)
- Dermatology Quality of Life - Daily Activities(Baseline, Days 3, 8, 15)
- Dermatology Quality of Life - Leisure(Baseline, Days 3, 8, 15)
- Dermatology Quality of Life - Work and School(Baseline, Days 3, 8, 15)
- Dermatology Quality of Life - Personal Relationships(Baseline, Days 3, 8, 15)
- Dermatology Quality of Life - Treatment(Baseline, Days 3, 8, 15)
- Total Dermatology Life Quality Index (DLQI) Score(Baseline, Days 3, 8, 15)
- Dermatology Life Quality Index (DLQI) Categories(Days 3, 8, 15)