NCT00988637已完成4 期
An Open-label, Multi-center, Randomized, Evaluator-Blinded Study to Evaluate the Safety and Efficacy of Two Treatment Regimens Involving Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05% in the Treatment of Moderate Plaque Psoriasis
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
- 138
- 试验地点
- 6
- 主要终点
- Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4
研究概览
简要总结
This clinical trial will evaluate the efficacy and safety of Clobex® (clobetasol propionate) Spray 0.05% and Vectical™ (calcitriol) Ointment 3 µg/g over a four week period of use in one of two different regimens:
- Vectical™ Ointment treatment, twice daily on weekdays (Mon - Fri) and Clobex® Spray treatment twice daily on weekends (Sat - Sun) for 28 days
- Clobex® Spray once each morning and Vectical™ Ointment once each evening for 28 days
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 (Outcomes Assessor)
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
- •Male or female subjects aged 18 to 80 years inclusive
- •Subjects with an Overall Disease Severity of 3 (moderate)
- •Subjects with 3% - 10% treatable BSA (Body Surface Area) excluding scalp, face, groin, axillae and/or other intertriginous areas
- •For concurrent medications, type and dose must have been stable for at least 3 months prior to study entry and not expected to change during the study. Subjects receiving treatment with beta-blockers or lithium, whose dose has been stable for at lest 6 months and who have shown no worsening of their psoriasis, may be included in the study, at the discretion of the investigator
排除标准
- •Subjects with intakes of more than 2,000 IU/day (50 mcg/day) of vitamin D (tolerable upper intake level) and/or more than 1,000 mg/day of calcium
- •Subjects whose psoriasis involves only the scalp, face, groin, axillae, and/or other intertriginous areas
- •Subjects with a wash-out period for topical treatment less than 30 days (Any steroid containing medication, dovonex, anthralin, tar and/or UVB treatment)
- •Subjects with a wash-out period for systemic treatment less than 12 weeks (corticosteroids, biologics and/or PUVA treatment; Examples of these therapies include, but are not limited to PUVA, Soriatane, Cyclosporine, Hydroxyurea, Mycophenolate mofetil, Sulfasalazine, Azathioprine, Alefacept, Efalizumab, Adalimumab, Etanercept, Infliximab, Rituximab, and Methotrexate)
- •Subjects with non-plaque psoriasis or other related diseases not classified as plaque psoriasis
- •Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
研究组 & 干预措施
1) Vectical™ Ointment and Clobex® Spray
Other
Vectical™ Ointment weekdays & Clobex® Spray weekends regimen
干预措施: Vectical™ Ointment weekdays and Clobex® Spray weekends regimen (Drug)
2) Clobex® Spray and Vectical™ Ointment
Other
Clobex® Spray morning and Vectical™ Ointment evening regimen
干预措施: Clobex® Spray morning and Vectical™ Ointment evening regimen (Drug)
结局指标
主要结局
Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 4 Based on the Overall Disease Severity (ODS), Full Ordinal Scale From Baseline to Week 4
时间窗: Baseline to Week 4
Number of participants who were a success (Clear/Almost Clear) of Plaque Psoriasis at week 4 based on the Overall Disease Severity (ODS), full ordinal scale from baseline to week 4. Overall Disease Severity is evaluated on a scale from 0 - 4 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe/Very Severe) with 0 being best and 4 being worst.
次要结局
- Number of Participants Who Were a Success (Clear/Almost Clear) of Plaque Psoriasis at Week 2 Based on the Overall Disease Severity (ODS), Dichotomized Scale From Baseline to Week 2(Baseline to week 2)
- Number of Participants With a Decrease in Signs of Psoriasis (Erythema) Scores From Baseline to Week 4(Baseline to Week 4)
- Number of Participants in Each Category of the Global Assessment of Improvement (GAI) Scale From Baseline to Week 4(Baseline to Week 4)
- Median Percent (%) Change From Baseline in % Treatable BSA (Body Surface Area) From Baseline to Week 4(Baseline to Week 4)
- Mean Change From Baseline Scores for the Koo-Menter Psoriasis Index 12-item Quality of Life Questionnaire (PQOL-12) From Baseline to Week 4(Baseline to Week 4)
- Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "The Treatment Program Was Easy to Follow" at Week 4(Baseline and Week 4)
- Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With my Appearance" at Week 4(Week 4)
- Number of Participants With Decrease in Signs of Psoriasis (Scaling) Scores From Baseline to Week 4(Baseline to Week 4)
- Number of Participants With Decrease in Signs of Psoriasis (Plaque Elevation) Scores From Baseline to Week 4(Baseline to Week 4)
- Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I am Satisfied With the Results of This Treatment Program" at Week 4(Week 4)
- Number of Participants Who Responded to the Categories of Possible Answers to the Subject's Satisfaction Survey Question "I Would Use This Treatment Program Again if Recommended by the Dermatologist" at Week 4(Week 4)
- Number of Participants With Tolerability Assessments Resulting in Adverse Events From Baseline to Week 4(Baseline to Week 4)
研究者
研究点 (6)
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