NCT01580488已完成1 期
A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris
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
- Change in the Total Clinical Score From Baseline to Day 22
研究概览
简要总结
The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
- •Age 18 years or above.
- •Males, or females of non-child bearing potential.
- •Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).
排除标准
- •Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
- •Female subjects who are pregnant, of child-bearing potential 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 islonger) for experimental biological products prior to randomisation and during the study.
- •Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study.
- •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.
- •Subjects using of phototherapy within the following time periods prior to randomisation and during the study:
- •PUVA (4 weeks)
- •UVB (2 weeks)
- •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 and/or facial psoriasis)
- •Topical retinoids
- •Vitamin D analogues
- •Topical immunomodulators (e.g. macrolides)
- •Anthracen derivatives
- •Salicylic acid.
- •Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- •Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
- •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
研究组 & 干预措施
未命名试验
干预措施: B LEO 35299 20 mg/g cream (Drug)
未命名试验
干预措施: C LEO 35299 20 mg/g cream (Drug)
未命名试验
干预措施: E LEO 35299 10 mg/g solution (Drug)
未命名试验
干预措施: F LEO 35299 10 mg/g solution (Drug)
未命名试验
干预措施: Daivonex® ointment (Drug)
未命名试验
干预措施: Daivonex® ointment vehicle (Drug)
结局指标
主要结局
Change in the Total Clinical Score From Baseline to Day 22
时间窗: Baseline to Day 22
Investigator's rating of the clinical appearance of a psoriatic lesion. Maximum score is 9 (most severe); minimum score is 0 (least severe). The single items erythema, scaling, and infiltration (maximum score 3 each) are summed to obtain the Total Clinical Score. Total Clinical Score range from 0 (all symptoms absent) to 9 (all symptoms severe)
次要结局
- Change in Erythema From Baseline to Day 22(Baseline to Day 22)
- Change in Skin Thickness From Baseline to Day 22(Baseline to Day 22)
- Change in Infiltration From Baseline to Day 22(Baseline to Day 22)
- Change in Scaling From Baseline to Day 22(Baseline to Day 22)
- Change in Lesion Thickness From Baseline to Day 22(Baseline to Day 22)
研究者
研究点 (1)
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