NCT01536938已完成2 期
LEO 90100 in the Treatment of Psoriasis Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 303
- 试验地点
- 33
- 主要终点
- Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
研究概览
简要总结
The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone are effective in the treatment of psoriasis vulgaris.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Signed and dated informed consent obtained prior to any trial related activities (including washout period).
- •Age 18 years or above
- •Either sex
- •Any race or ethnicity
- •All skin types
- •Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).
- •Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
- •Able to communicate with the investigator and understand and comply with the requirements of the study.
排除标准
- •Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- •etanercept - within 4 weeks prior to randomisation
- •adalimumab, alefacept, infliximab - within 8 weeks prior to randomisation
- •ustekinumab - within 16 weeks prior to randomisation
- •other products - 4 weeks/5 half-lives (whichever is longer)
- •Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.
- •Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
- •PUVA therapy within 4 weeks prior to randomisation.
- •UVB therapy within 2 weeks prior to randomisation.
- •Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the study.
- •Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the study.
- •Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- •Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds.
- •Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris.
- •Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
- •Known or suspected severe renal insufficiency or severe hepatic disorders.
- •Known or suspected hypersensitivity to component(s) of the investigational products.
- •Current participation in any other interventional clinical study.
- •Previously randomised in this study.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
研究组 & 干预措施
Calcipotriol
Active Comparator
Calcipotriol aerosol foam: calcipotriol 50 mcg/g.
Applied once daily for up to 4 weeks
干预措施: Calcipotriol (Drug)
Betamethasone
Active Comparator
Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)
Applied once daily for up to 4 weeks
干预措施: Betamethasone (Drug)
LEO 90100
Experimental
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Applied once daily for up to 4 weeks
干预措施: LEO 90100 (Drug)
结局指标
主要结局
Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
时间窗: 4 weeks
Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.
次要结局
未报告次要终点
研究者
研究点 (33)
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