NCT02606760已完成3 期
A Randomized, Double-blind, Vehicle-controlled, Parallel Group Trial to Assess the Efficacy, Safety and Tolerability of P-3073 for Topical Treatment of Nail Psoriasis
Polichem S.A.0 个研究点目标入组 378 人开始时间: 2015年11月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 378
- 主要终点
- Change in total Nail Psoriasis Severity Index (NAPSI)
研究概览
简要总结
The purpose of this study is to confirm the clinical efficacy and the safety of P-3073 in patients affected by isolated psoriatic nail(s) and/or those with psoriatic nails and concomitant mild to moderate plaque psoriasis.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Written informed consent before starting any study related procedures
- •Patients aged 18 to 80 years old of any race.
- •Males or females.
- •Patients with mild to moderate psoriastic fingernail(s) defined as fingernail/s with matrix psoriasis NAPSI score and/or bed psoriasis NAPSI score ≥ 1 and ≤ 3 at baseline.
- •In case of skin involvement, patients with established clinical diagnosis of mild-to-moderate psoriasis (BSA involvement ≤ 8% or PASI ≤ 10)
排除标准
- •Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- •Use of any systemic treatment for psoriasis during the last six months before the screening visit.
- •Use of photochemotherapy or other forms of radiotherapy during the last four weeks before the screening visit.
- •Positive mycology findings
- •Systemic use of immunosuppressives, chemotherapy and corticosteroids during last three months before the screening visit.
- •Consumption of Vitamin D or its analogues during the last three months.
- •History of hypercalcaemia or hypercalciuria.
- •HIV infection or any other immunodeficiency.
- •Alcohol or substance abuse.
- •Patients with history of allergic reactions to calcipotriol or its excipients.
研究组 & 干预措施
P-3073
Experimental
P-3073
干预措施: P-3073 (Drug)
vehicle of P-3073
Placebo Comparator
vehicle of P-3073
干预措施: Vehicle of P-3073 (Drug)
结局指标
主要结局
Change in total Nail Psoriasis Severity Index (NAPSI)
时间窗: Baseline - Week 24
次要结局
- Change in NAPSI bed(Week 24)
- Proportions of nails with improvement in total NAPSI(Week 24)
- Nail Physician Global Assessment (PGA) response rate(Week 24)
- Proportions of nails with improvement in NAPSI Matrix(Week 24)
- Change in NAPSI matrix(Baseline - Week 24)
- Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation.(Week 24)
- Change in patient's quality-of-life by means of the Dermatology Life Quality Index (DLQI)(Baseline - Week 24)
- Change in discomfort by means of the Visual Analogue Scale (VAS)(Week 24)
- Proportions of nails with improvement in NAPSI bed(Week 24)
研究者
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