Multi-center,Single Blind, Parallel-Controlled Study of the Efficacy and Safety of Calcipotriol Betamethasone Ointment Plus Calcipotriol Ointment in Sequential Therapy to Psoriasis Vulgaris
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index 50 ,75 and 90
研究概览
简要总结
Evaluate the efficacy and safety of Calcipotriol Betamethasone Ointment and Calcipotriol Ointment in sequential therapy
详细描述
1.240 subjects will be randomized 1:1:1 divided into the 3 groups 2.Week0 to Week4,each group were treated with Calcipotriol Betamethasone Ointment 3.Week4 to Week12, the there group were respectively treated with Calcipotriol Betamethasone Ointment,Calcipotriol Ointment and Urea Cream 4.The efficacy and safety were evaluated at the baseline, as well as 1, 4, 8 and 12 weeks after the beginning 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who signed Informed Consent Form；
- •Male or female subjects 18-65 years of age；
- •Clinically confirmed diagnosis of plaque psoriasis as per the diagnostic criteria for psoriasis vulgaris specified in Clinical Dermatology.
- •Involved area 1-10% of the body surface area.
排除标准
- •Incompliance with the diagnosis of plaque psoriasis or plaque area > 10% of the body surface area.
- •Erythrodermic psoriasis, psoriasis arfhropathica or pustular psoriasis;
- •Known allergy to any component of the test or control drug；
- •Concomitant allergic skin disease such as eczema， contact dermatitis and urticaria, or other serious and/or extensive skin disease；
- •Systemic medication or ultraviolet therapy for psoriasis within 4 weeks prior to study initiation；
- •Topical use of external drug for psoriasis within 2 weeks prior to study initiation；
- •Women of child-bearing potential who are pregnant, plan to become pregnant during study or are lactating；
- •Glucocorticoid or immunodepressant, or hypoleukemia due to tumor or chemotherapy within the last 4 weeks；
- •Serious life-threatening condition that allows a life expectancy of less than 2 months；
- •Inability to guarantee taking medications and completing visits as scheduled during the study;
- •Serious infection that is not suitable for external treatment；
- •Any other condition that the investigator deems unsuitable for entering the study.
研究组 & 干预措施
Calcipotriol/Betamethasone and Calcipotriol
Calcipotriol/Betamethasone ointment 1/d for 4 weeks; Calcipotriol ointment bid for 6 weeks on-demand treatment period;
干预措施: Calcipotriol Betamethasone ointment and Calcipotriol ointment (Drug)
Calcipotriol/Betamethasone and urea cream
alcipotriol/Betamethasone ointment 1/d for 4 weeks , urea cream 1/d for 6 weeks on-demand treatment period
干预措施: Calcipotriol Betamethasone ointment and Urea Cream (Drug)
Calcipotriol/Betamethasone
Calcipotriol/Betamethasone ointment 1/d for 4 weeks, Calcipotriol/Betamethasone ointment 1/d for 6 weeks on-demand treatment period
干预措施: Calcipotriol Betamethasone ointment (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index 50 ,75 and 90
时间窗: week0 and week12
次要结局
- Time to recurrence(Any Point In Time after 4 weeks)
研究者
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Wang Gang
Xijing Hospital