NCT00216840已完成3 期
Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle and Calcipotriol in the Gel Vehicle in Scalp Psoriasis
适应症
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
- 1,350
- 试验地点
- 14
- 主要终点
- - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
研究概览
简要总结
The purpose of the study is to evaluate whether once daily topical treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis.
The primary response criterion is the number of patients with absence of disease and very mild disease after 8 weeks of treatment.
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
- Double
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
- •Scalp psoriasis amenable to topical treatment with a maximum of 100 g of medication per week
- •Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
- •Extent of scalp psoriasis involving more than 10% of the total scalp area
- •Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs
- •Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity
排除标准
- •PUVA or Grenz ray therapy within 4 weeks prior to randomisation
- •UVB therapy within 2 weeks prior to randomisation
- •Systemic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation
- •Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation
- •Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation
- •Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation
- •Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
结局指标
主要结局
- Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.
次要结局
- - Score for scaliness, redness and thickness at week 8
- - Evaluation of Adverse Events
- - Patients with "Treatment success" ("Almost clear" or "Cleared") according to patient's overall assessment of disease severity at week 8
- - Evaluation of Laboratory Data
- - Total sign score at week 8
- - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 2 and 4
研究者
研究点 (14)
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