NCT00670241已完成3 期
A Phase 3 Study Comparing a Gel Containing Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) With Tacalcitol Ointment (4 mcg/g) and Gel Vehicle, Used Once Daily in the Treatment of Psoriasis Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8
研究概览
简要总结
This study will compare efficacy and safety of once daily treatment of calcipotriol plus betamethasone dipropionate gel (LEO 80185) with tacalcitol ointment and LEO 80185 vehicle alone in subjects with psoriasis vulgaris. Subjects will be treated for up to 8 weeks followed by an observation period of up to 8 weeks to investigate the occurence and the time to relapse and occurence of rebound after discontinuation of the investigational products. Only subjects with "controlled disease" will be considered for this observation phase of the study. "Controlled disease" is defined as "Clear" or "Almost Clear" severity category based on Investigator's global assessment (IGA).
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
- 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
- •Signed and dated informed consent to be obtained prior to any trial related procedure, including wash-out
- •Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of LEO 80185 gel per week or 10 g per day of tacalcitol ointment
- •Disease severity graded moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity
- •A minimum PASI score for extent of 2 in at least one body region (i.e.psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
- •Subjects aged 18 years or above
- •Either sex
- •Any ethnic origin
- •Attending hospital outpatient clinic or the private practice of a dermatologist
排除标准
- •Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
- •Systemic treatment with all other therapies than biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation
- •Systemic treatment with Vitamin D preparations above 500 IU per day
- •PUVA or Grenz ray therapy within 4 weeks prior to randomization
- •UVB therapy within 2 weeks prior to randomisation
- •Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation
- •Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with potent or very potent (WHO group III-IV) corticosteroids or vitamin D analogues within 2 weeks prior to randomisation
- •Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with very potent (WHO group IV) corticosteroids or vitamin D analogues within 2 weeks prior to randomisation
- •Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) during the study
- •Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
- •Subjects with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atro-phicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
- •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
- •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, except for biologics (3 months)
- •Planned exposure to sun during the study that may affect psoriasis vulgaris
- •Previously randomised to this study
- •Subjects known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychotic state)
- •Females of child-bearing potential wishing to become pregnant during the study, or are breast-feeding, or not using an adequate method of contraception during the study
- •Females of child-bearing potential with positive pregnancy test at Visit 1
研究组 & 干预措施
1
Active Comparator
干预措施: calcipotriol and betamethasone (LEO 80185 gel) (Drug)
2
Active Comparator
干预措施: Tacalcitol ointment (Drug)
3
Placebo Comparator
干预措施: LEO 80185 vehicle (Drug)
结局指标
主要结局
Subjects With "Controlled Disease" ("Clear" or "Almost Clear" Disease) According to Investigator's Global Assessment of Disease Severity at Week 8
时间窗: Week 8
次要结局
- Subjects With Rebound During the Study(Week 8-16)
- Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity at Week 4(Week 4)
- The Percentage Change in PASI From Baseline to Week 8(Baseline, Week 4 and 8)
- Subjects With Relapse During the Study(Week 8-16)
研究者
研究点 (1)
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