NCT03331523已完成3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd) to the Marketed Product Taclonex® Topical Suspension (LEO Pharma Inc.) in the Treatment of Scalp Psoriasis
Glenmark Pharmaceuticals Ltd. India31 个研究点 分布在 1 个国家目标入组 643 人开始时间: 2017年10月20日最近更新:
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
- 入组人数
- 643
- 试验地点
- 31
- 主要终点
- Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.
研究概览
简要总结
This is a phase III, randomized, double-blind, placebo-controlled, parallel- group, multiple-site study to evaluate the therapeutic equivalence of generic calcipotriene and betamethasone dipropionate topical suspension, 0.005%/0.064% of Glenmark Pharmaceuticals Ltd to that of the marketed product Taclonex® topical suspension of Leo Pharma Inc. in the treatment of scalp psoriasis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or non-pregnant, non-lactating female subjects aged at least 18 years at Visit
- •A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp and clinical signs of psoriasis vulgaris on trunk and/or limbs.
- •A PGA of disease severity of the scalp psoriasis consistent with at least moderate disease severity (Grade ≥ 3).
- •A plaque elevation of at least moderate severity (Grade ≥ 3) at the scalp target lesion site. The most severe scalp lesion at baseline should be identified as the target lesion.
排除标准
- •Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis.
- •Other inflammatory skin disease in the scalp that may confound the evaluation of the scalp psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea capitis).
- •Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the scalp that could interfere with the rating of efficacy parameters.
- •Presence of viral lesions, fungal, bacterial, or parasitic infections and/or atrophic (thinning) skin on the scalp.
- •History of psoriasis unresponsive to topical treatments.
- •Subjects with planned phototherapy and/or exposure to ultraviolet A (UVA) and/or UVB during the study.
研究组 & 干预措施
Taclonex®
Active Comparator
干预措施: Taclonex® (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Calcipotriene/betamethasone dipropionate
Experimental
干预措施: Calcipotriene/Betamethasone Dipropionate (Drug)
结局指标
主要结局
Proportion of subjects in each treatment group with clinical success, defined as a score of 0 or 1, at the target lesion site on the PASI scale at the end of study visit.
时间窗: Day 29
Proportion of subjects in each treatment group with treatment success, defined as a score of 0 or 1, within the treatment area(s) on the PGA scale of disease severity, at the end of study visit.
时间窗: Day 29
次要结局
未报告次要终点
研究者
研究点 (31)
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