NCT01105286已完成1 期
A Psoriasis Plaque Test Comparing Eight Different Formulations of Vitamin D Analogues for the Treatment of Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Total Clinical Score of clinical symptoms
研究概览
简要总结
The purpose of this trial is to compare the anti-psoriatic effect of eight different formulations of vitamin D analogues using a psoriasis plaque test design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (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
- •Subjects having understood and signed an informed consent form.
- •Either sex
- •Age 18 years or above
- •All skin types and any ethnic origin
- •Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk.
排除标准
- •Females who are pregnant, or who wish to become pregnant during the study, or who are breast feeding
- •Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
- •Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immuno-suppressants) within the 4-week period prior to randomisation
- •Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
- •Potent or very potent (WHO group III-IV) corticosteroids
- •PUVA or Grenz ray therapy
- •Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
- •WHO group I-II corticosteroids (except if used for treatment of scalp psoriasis)
- •Topical retinoids
- •Vitamin D analogues
- •Topical immunomodulators (e.g. macrolides)
- •Anthracen derivatives
- •Salicylic acid
- •UVB therapy
- •Subjects known to be non-responder to topical vitamin D analogues (e.g., known history of no improvement or worsening of psoriasis with e.g., calcipotriol, calcitriol or tacalcitol when used according to current SmPc)
- •Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
- •Subjects with current participation in any other interventional clinical, based on interview of the subject
- •Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- •Subjects with known or suspected hypersensitivity to component(s) of the investigational products
- •Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia
- •Subjects with known severe hepatic and/or severe renal insufficiency
- •Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis
研究组 & 干预措施
Calcipotriol ointment
Experimental
干预措施: Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues (Drug)
结局指标
主要结局
Total Clinical Score of clinical symptoms
时间窗: 4 weeks
次要结局
- Clinical scores, lesions thickness(4 weeks)
研究者
研究点 (1)
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