NL-OMON37524已完成4 期
Optimising outpatient care in mild to moderate psoriasis by a newly developed *Topical Treatment Optimising Programme* - an international study using Daivobet®/Dovobet® Gel (*PSO-TOP*) - PSO-TOP
SCIderm GmbH0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male and female patients aged at least 18 years
- •- Mild to moderate active plaque psoriasis with a PGA * 2 on the 7 point scale by Langley and Ellis and a Body Surface Area (BSA) of * 10%
- •- Topical psoriasis treatment with coal or tar preparations, tazarotene, steroids, or vitamin D analogues, or combinations of steroids and vitamin D analogues (except gel combination products containing 50 micrograms calcipotriol / 0.5 mg betamethasone/g) or dithranol and its combination preparations over the last 8 weeks prior to Visit 1 (week 0)
- •- Written informed consent to participate in the study has been given prior to any study related procedures
排除标准
- •- Severe renal insufficiency
- •- Severe hepatic disorders
- •- Known hyper calcaemia
- •- Erythrodermic, exfoliative, pustular or guttate psoriasis
- •- Facial or genital psoriasis
- •- Fulfilment of at least one contraindication according to the Summary of Product Characteristics of Daivobet®/Dovobet®
- •- Pregnant and/or breast-feeding women
- •- Hypersensitivity to the active substances or to any of the excipients
- •- Suspected non-compliance with the clinical study procedures
- •- Current participation in another clinical study
- •- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to Visit 1 (week 0):
- •* etanercept * within 4 weeks prior to Visit 1 (week 0)
- •* adalimumab, alefacept, infliximab * within 2 months prior to Visit 1 (week 0)
- •* ustekinumab * within 4 months prior to Visit 1 (week 0)
- •* experimental products * within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1 (week 0)
- •- Phototherapy within the following time periods prior to Visit 1 (week 0):
- •* PUVA * within 4 weeks prior to Visit 1 (week 0)
- •* UV-B * within 2 weeks prior to Visit 1 (week 0)
研究者
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