NCT01297166已完成1 期
A Psoriasis Plaque Test on LEO 27989 Ointment and Calcipotriol Plus LEO 27989 Ointment in Patients With 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
- 25
- 试验地点
- 1
- 主要终点
- Absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment compared to baseline.
研究概览
简要总结
The purpose of this study is to evaluate the anti-psoriatic effect of LEO 27989 ointment and calcipotriol plus LEO 27989 ointment, 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
- 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
- •Age 18 years or above
- •Males, or females of non-child bearing potential
- •All skin types
- •Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk.
- •Exclusion criteria:
- •Male who are not willing to use a local contraception (such as condom) for the entire duration of the study, and refrain from fathering a child within 3 months following the last study drug application
- •Females who are pregnant, of child-bearing potential and 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 and during the study
- •Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) 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
- •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 and/or facial psoriasis)
- •Topical retinoids
- •Vitamin D analogues
- •Topical immunomodulators (e.g. macrolides)
- •Anthracen derivatives
- •Salicylic acid
- •UVB therapy
- •Subjects using emollients on the target plaques within one week before randomisation and during the study
- •Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the study
- •Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- •Subjects with known/suspected disorders of calcium metabolism associated with hypercalcaemia based on medical history
- •Subjects with a positive Hepatitis B, Hepatitis C or HIV test
- •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 known or suspected hypersensitivity to component(s) of the investigational products
- •History of any severe disease or serious current condition (based on subject interview and/or results of screening physical examination) which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere significantly with the evaluation of study results or the study course (e.g. cancer, severe cardiopathy, severe renal insufficiency, severe hepatic insufficiency).
- •Subjects with a positive Hepatitis B, Hepatitis C or HIV test
- •Subjects with any concomitant medical or dermatological disorder(s) which might preclude accurate evaluation of the psoriasis on the test areas
- •Subjects foreseeing an intensive solar exposure during the study (UV radiation, etc.) or having been exposed within two weeks preceding the screening visit
- •Subjects with any contraindication to skin biopsy procedures: e.g., allergy to local anaesthetics, topical antiseptics (chlorhexidine), bleeding tendency, treatment with anticoagulant drugs, history of poor wound healing, and history of vasovagal hypotension or syncope.
排除标准
- 未提供
研究组 & 干预措施
LEO 27989 ointment
Experimental
干预措施: LEO 27989 ointment (Drug)
LEO 27989 ointment
Experimental
干预措施: Calcipotriol plus LEO 27989 ointment (Drug)
LEO 27989 ointment
Experimental
干预措施: Calcipotriol ointment (Drug)
LEO 27989 ointment
Experimental
干预措施: Vehicle ointment (Drug)
结局指标
主要结局
Absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) at end of treatment compared to baseline.
时间窗: 3 weeks
TCS range from 0 (all symptoms absent) to 9 (all symptoms severe)
次要结局
- Lesion thickness(3 weeks)
- Immunohistochemical and histologic scoring of biopsy material(3 weeks)
- Clinical sympton scores(3 weeks)
- Intra-subject variability(3 weeks)
研究者
研究点 (1)
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