NCT02601703已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (Tacrolimus) Ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD)
Glenmark Pharmaceuticals Ltd. India60 个研究点 分布在 1 个国家目标入组 1,110 人开始时间: 2015年8月最近更新:
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
- 1,110
- 试验地点
- 60
- 主要终点
- Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
研究概览
简要总结
This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).
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
- Triple (Participant, 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
- •Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD.
- •Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka
- •Have an IGA score of 3 (moderate) or 4 (severe).
- •Have an affected Body Surface Area (BSA) of at least 20% at baseline.
- •Treated with a bland emollient for at least 7 days.
排除标准
- •Active cutaneous bacterial or viral infection in any treatment area at baseline.
- •Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.
- •History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
- •History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
- •Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.
研究组 & 干预措施
Tacrolimus Ointment 0.1%
Experimental
干预措施: Tacrolimus Ointment 0.1% (Drug)
Protopic® ointment, 0.1%
Active Comparator
干预措施: Protopic® ointment, 0.1% (Drug)
Placebo of Tacrolimus Ointment
Placebo Comparator
干预措施: Placebo of Tacrolimus Ointment (Drug)
结局指标
主要结局
Investigator's Global Assessment (IGA) score of 0 or 1 within all treatment areas at the end of treatment
时间窗: Day 15
次要结局
- The change in severity score from baseline to study Day 15 of the four individual signs and symptoms of AD (i.e., erythema, induration/papulation, lichenification and pruritus).(Day 15)
研究者
研究点 (60)
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