NCT00883311已完成2 期
A Clinical Usage Study to Evaluate the Safety and Efficacy of BRT-FC-83C in the Management of Mild to Moderate Atopic Dermatitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site
研究概览
简要总结
The purpose of the study is to determine whether the topical application of BRT-FC-83C is effective in the treatment of mild to moderate atopic dermatitis.
详细描述
Atopic dermatitis is a common skin disease. BRT-FC-83C is a skin cream that does not contain corticosteroids or other anti-inflammatory components. It represents a novel class of skin barrier repair therapy for chronic dermatoses. The objective of this clinical study is to determine whether BRT-FC-83C, applied twice a day to the affected area of the skin, ameliorates signs and symptoms of mild to moderate atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically verified mild to moderate atopic dermatitis. Atopy diagnosis based on clinical scores of 3-7.5 based on the Rajka and Langeland criteria
- •Men or women ages 18-50 years
- •At least one mild to moderate atopic lesion involving no more than 20% Body Surface Area (BSA)
- •Active atopic dermatitis for at least 3 years
- •Willingness to cooperate and participate by following study requirements
- •Written informed consent
排除标准
- •Individuals with actively oozing atopic lesions
- •Individuals who are smokers
- •Individuals with insulin-dependent diabetes mellitus
- •Individuals that are known to be pregnant, nursing, or planning to become pregnant within the next six months after enrollment
- •Individuals currently participating in another clinical usage study that would interfere with this study
结局指标
主要结局
Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site
时间窗: Eight weeks
次要结局
- Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site(Eight weeks)
- Change in mean corneometer measurement in lesional skin at target site(Eight weeks)
- Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis(Eight weeks)
- Change in Investigator's Global Assessment (IGA) in lesional skin at target site(Eight weeks)
研究者
研究点 (2)
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