NCT00640822已完成3 期
A Phase 3 Study Comparing an Ointment Containing Calcipotriol 25 mcg/g Plus Hydrocortisone 10 mg g With Tacalcitol 4 mcg/g Ointment and the Ointment Vehicle Alone, All Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and on the Intertriginous Areas
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
- 782
- 试验地点
- 3
- 主要终点
- Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
研究概览
简要总结
There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares
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
- •Clinical diagnosis of psoriasis vulgaris involving the face
- •Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
- •An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
- •Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 10 g of ointment per day
- •Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face
排除标准
- •Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
- •Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
- •PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
- •UVB therapy within the 2-week period prior to randomisation
- •Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the study)
- •Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
- •Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
- •Systemic treatment with vitamin D preparations above 500 IU per day
- •Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
- •Patients 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, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
- •Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas
- •Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
- •Known or suspected severe renal insufficiency or severe hepatic disorders
- •Known or suspected disorders of calcium metabolism associated with hypercalcemia
研究组 & 干预措施
Calcipotriol plus Hydrocortisone ointment
Experimental
Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks
干预措施: Calcipotriol plus hydrocortisone ointment (Drug)
Tacalcitol
Active Comparator
Tacalcitol once daily for up to 8 weeks
干预措施: Tacalcitol Ointment (Drug)
Calcipotriol plus Hydrocortisone ointment vehicle
Placebo Comparator
Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks
干预措施: Calcipotriol plus hydrocortisone ointment vehicle (Drug)
结局指标
主要结局
Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8
时间窗: Week 8
次要结局
- Total Sign Score of the Intertriginous Areas(Week 8)
- Total Sign Score of the Face(Week 8)
- Patients With Relapse During the Study and Time to Relapse(Week 8-16)
- Severity Scores for Redness, Thickness and Scaliness of the Face(Week 8)
- Patients With Rebound During the Study(Week 8-16)
- Overall Disease Severity of the Face According to the Investigator's Assessment(Week 4)
- Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment(Week 8)
研究者
研究点 (3)
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