NCT01700985已完成2 期
A Double-Blind, Randomized, Single Center, Vehicle-Controlled, Parallel Group Study to Determine the Efficacy and Safety of 122-0551 in Subjects With Plaque Psoriasis Receiving Two Weeks of Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in Overall Disease Severity (ODS) Score
研究概览
简要总结
Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive 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
- Double (Participant, 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
- •Subject has a clinical diagnosis of stable plaque psoriasis
- •Subject has an ODS score for the Treatment Area of 3 or 4 at study start
排除标准
- •Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- •Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
- •Subject has used any phototherapy, photo-chemotherapy or systemic corticosteroid therapy within 30 days prior to study start
- •Subject has used any systemic methotrexate, retinoids, cyclosporine or analogous products within 90 days prior to study start
- •Subject has used any systemic biologic therapy for the treatment of psoriasis within 5 half-lives of the biologic prior to study start
- •Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start
- •Subject has used topical body (excluding the scalp) psoriasis therapy including coal tar, anthralin, steroids, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to study start
- •Subject has used emollients/moisturizers on areas to be treated within four hours prior to clinical evaluation at study start
- •Subject is currently using lithium or Plaquenil (hydroxychloroquine)
- •Subject is currently using a beta-blocking medication (e.g., propranolol) or ACE (e.g., lisinopril) inhibitor at a dose that has not been stabilized
- •Subject is pregnant, lactating, or is planning to become pregnant during the study
- •Subject is currently enrolled in an investigational drug or device study
- •Subject has used an investigational drug or investigational device treatment within 30 days prior to study start
- •Subject has been previously enrolled in this study and treated with a test article
研究组 & 干预措施
122-0551
Experimental
干预措施: 122-0551 (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Change in Overall Disease Severity (ODS) Score
时间窗: baseline and Day 15 (End of Study - EOS)
The percentage of subjects with ODS "treatment success" at EOS where EOS is the subject's last completed visit. "Treatment success" is defined as an ODS of 0 or 1. ODS is measured on a 5-point scale: 0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe/very severe.
次要结局
- ODS "Improved" at Day 8 and Day 15(baseline, Day 8, and Day 15)
- "Treatment Success" for Clinical Signs and Symptoms of Psoriasis(baseline, Day 8 and Day 15)
- ODS "Treatment Success" at Day 8 and Day 15(baseline, Day 8, and Day 15)
- "Improved" for Clinical Signs and Symptoms of Psoriasis(baseline, Day 8 and Day 15)
- Change in % Body Surface Area (BSA) With Psoriasis(baseline, Day 8 and Day 15)
研究者
研究点 (2)
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