NCT00373516已完成2 期
A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Study of the Safety and Efficacy of Two Dosing Regimens of QRX-101 (Becocalcidiol) Ointment in the Treatment of Plaque-Type Psoriasis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of two dosing regimens of QRX-101 ointment (75 mcg/g QD and 75mcg/g BID) in the treatment of plaque-type psoriasis when applied topically twice daily for 8 weeks
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
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
- •Clinical diagnosis of stable plaque-type psoriasis affecting 2% to 10% of the subject's body surface area
- •Psoriasis of a severity that is appropriate for treatment with topical therapy; PGA of at least 3 (moderate) at baseline; PSS of at least 7, and with no individual symptom score (erythema, induration, or scaling) less than 2
- •Subject must sign the IRB approved informed consent and agree to follow dosing instructions and complete required clinic visits.
排除标准
- •Pregnant or nursing females
- •Systemic corticosteroids, methotrexate, cyclosporine, systemic retinoids, prolonged sun exposure or ultraviolet light therapy within 4 weeks of dosing
- •Topical corticosteroids, retinoids, calcipotriene, coal tar, anthralin, or any other treatment indicated for psoriasis within 2 weeks of dosing
- •Untreated bacterial, tubercular, fungal or any viral lesion of the skin
- •Biologic agents/monoclonal antibodies in the last 6 months
- •Currently using lithium or plaquenil
- •Currently using a beta-blocking medication or thiazide diuretic and the dose has not been stabilized for at least 6 months
- •History of hypercalcemia or evidence of vitamin D toxicity
- •Current or history of melanoma skin cancer in the past 5 years
结局指标
主要结局
Dichotomized Physician's Static Global Assessment of Overall Lesion Severity (PGA)at Week 8
Percent Change from Baseline in Psoriasis Symptom Severity (PSS)Scale at Week 8
次要结局
- Dichotomized PGA at weeks 2 and 4
- Ordinal PGA at weeks 2, 4, and 8
- Percent change from baseline PSS at weeks 2 and 4
- Ordinal PSS at weeks 2, 4, and 8
- Individual symptom scores (erythema, induration, and scaling) at weeks 2, 4, and 8
- Body surface area (BSA) involvement at weeks 2, 4, and 8
研究者
研究点 (13)
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