A Study to Evaluate the Efficacy and Tolerability of Clobetasol Propionate vs. Vehicle in the Treatment of Mild to Moderate Plaque-Type Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4
研究概览
简要总结
The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.
详细描述
The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient, male or female of any race, and at least 12 years of age. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study.
- •Mild to moderate, plaque-type psoriasis
- •Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees) with a score of 2 or 3 for each of erythema, scaling and plaque thickness
- •Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization Forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.
排除标准
- •Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who are of childbearing potential and not practicing a reliable method of birth control
- •Known allergy to clobetasol propionate or other topical corticosteroids; or to any component of the investigational formulations
- •Subjects who have not complied with the proper wash-out periods for prohibited medications
- •Medical condition that in the opinion of the investigator, contraindicates the subject's participation in the clinical study
- •Skin disease/disorder that might interfere with the study related diagnosis or evaluations
- •Evidence of recent alcohol or drug abuse
- •History of poor cooperation, non-compliance with medical treatment or unreliability
研究组 & 干预措施
Clobetasol Propionate Foam
Topical foam formulation that includes clobetasol propionate (Steroid)
干预措施: Clobetasol propionate foam (Drug)
Vehicle Foam
Vehicle foam is the same as the clobetasol propionate foam except it does not include the active drug.
干预措施: Vehicle foam (Drug)
结局指标
主要结局
Number of Participants With a Target Lesion Global Improvement (TLGI) Score of 0, 1, or 2 at Weeks 1, 2, and 4
时间窗: Weeks 1, 2, and 4
The investigator assessed the TLGI of participants relative to their initial Baseline condition based on a 7-point scale: 0=completely cleared, possible residual discoloration; 1=almost cleared, 90% improvement, very significant clearance with only traces of disease remaining; 2=marked improvement, approximately 75%, with some disease remaining; 3=moderate improvement, approximately 50%; 4=mild improvement, approximately 25%, significant disease remains; 5=no change, no detectable improvement; 6=excerbation, worsening of signs and symptoms of disease.
次要结局
- Number of Participants With a TLGI Score of 0, 1, 2, or 3 at Weeks 1, 2, and 4(Weeks 1, 2, and 4)
- Number of Participants With a Plaque Thickness Score of 0 or 1 at Week 2(Week 2)
- Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Week 2(Week 2)
- Number of Participants With an Erythema Score of 0 or 1 at Baseline and Week 4(Baseline (Week 0) and Week 4)
- Number of Participants With a Scaling Score of 0 or 1 at Baseline and Week 4(Baseline (Week 0) and Week 4)
- Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Week 2(Week 2)
- Number of Participants With an Erythema Score of 0 or 1 at Week 2(Week 2)
- Number of Participants With a Scaling Score of 0 or 1 at Week 2(Week 2)
- Mean Percent Change From Baseline to Week 2 in Pruritus (Target Lesion)(Baseline (Week 0) and Week 2)
- Mean Percent Change From Baseline to Week 2 in Percent (%) of Body Surface Area (BSA) Affected(Baseline (Week 0) and Week 2)
- Number of Participants With a TLGI Score of 0, 1, or 2 at Week 1 and Week 4(Week 1 and Week 4)
- Number of Participants With a Pruritus (Overall) Score of 0 or 1 at Baseline and Week 4(Baseline (Week 0) and Week 4)
- Number of Participants With a Plaque Thickness Score of 0 or 1 at Baseline and Week 4(Baseline (Week 0) and Week 4)
- Mean Percent Change From Baseline to Week 4 in Pruritus (Target Lesion)(Baseline (Week 0) and Week 4)
- Number of Participants With a Score of 0 or 1 for Subject Global Assessment at Baseline and Week 4(Baseline (Week 0) and Week 4)
- Mean Percent Change From Baseline to Week 4 in Percent (%) of Body Surface Area (BSA) Affected(Baseline (Week 0) and Week 4)