A prospective, randomized, double blind, two arm, comparative clinical study to evaluate the safety and efficacy of Nixoderm tin for treating atopic dermatitis in adult subjects.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- assessed by Atopic Dermatitis Severity Index (ADSI) and photographic
研究概览
简要总结
Atopic dermatitis is the most common chronic inflammatory skin disease globally with huge socioeconomic implications, particularly in patients with moderate-to-severe disease. Atopic dermatitis commonly starts during the first year of life and affects over 200 million individuals worldwide, with estimated prevalence rates of up to 15–25% in children and 3–7% in adults. Some patients experience long-term resolution of their skin symptoms, whereas others have atopic dermatitis for their entire lives. The risk of persistence into adulthood is somewhat increased in individuals with later onset or a more severe atopic dermatitis course, but data differ greatly across studies. Despite an increased understanding of the pathogenesis of atopic dermatitis, there are no available biomarkers that can predict disease course. Although the traditional systemic therapeutics are broad-acting immunosuppressants with potentially deleterious long-term side-effects, novel, targeted agents have substantially broadened the therapeutic armamentarium. For decades, long-term disease control and maintenance were particularly challenging given that treatment options were limited to broad topical and systemic immunosuppressive agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Male and Female volunteers aged between 18-60 years.
- •Participants diagnosed with of mild to moderate atopic dermatitis.
- •Willing to give Informed Consent
- •Willing to complete the study assessments/questionnaires.
- •Willing to avoid usage of his/her own skin care products in controlling atopic dermatitis for at least one week before the commencement and during this study.
排除标准
- •Pregnancy or breast feeding.
- •Patients with inflammatory or infective skin conditions.
- •Patients with history of hypersensitivity to skin care products.
- •Patients with mild to severe anaphylaxis reaction.
- •Patients with pre-existing severe systemic disease necessitating long-term medication.
- •Evidence of significant uncontrolled co-morbid disease which in the investigators opinion would jeopardize patient participation.
- •History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.
- •Participation in the current or previous clinical trial with any approved or investigational products during the past 1 month.
结局指标
主要结局
assessed by Atopic Dermatitis Severity Index (ADSI) and photographic
时间窗: Day0,Day7,Day15,Day30.
• Percentage reduction of erythema, edema and papulation would be assessed
时间窗: Day0,Day7,Day15,Day30.
through Eczema Area and Severity Index (EASI) from baseline to end of the
时间窗: Day0,Day7,Day15,Day30.
Primary Outcomes:
时间窗: Day0,Day7,Day15,Day30.
1.Percentage reduction in atopic dermatitis from baseline visit to last visit
时间窗: Day0,Day7,Day15,Day30.
evaluation.
时间窗: Day0,Day7,Day15,Day30.
study.
时间窗: Day0,Day7,Day15,Day30.
次要结局
- Secondary Outcomes:(1.Change from baseline in the Dermatological assessment [All)
