Phase II Double Blind Placebo-controled Randomized Comparative Multicentered Study of Efficacy and Safety of Lactofiltrum, Orally Administered Tablets (Produced by AVVA RUS, JSC) to Treat Atopic Dermatitis in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- SCORAD Index
研究概览
简要总结
The purpose is to study efficacy of Lactofiltrum in adult patients with atopic dermatitis. Lactofiltrum consists of 85% of hidrolytic lignin and 15% of lactulose and acts as an enterosorbent, which enables to enhance metabolism and elimination of endotoxins and to normalize metabolic and immune processes. Additionally, lactulose stimulates Bifidobacterium flora and in aggregate it could improve skin condition afflicted by atopic dermatitis.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 18-60 y.o. diagnosed with atopic dermatitis according to the UK refinement of the Hanifin-Rajka diagnostic criteria;
- •SCORAD Index more than 25.
排除标准
- •pregnancy and breast-feeding;
- •severe diseases;
- •concomitant infection diseases (including parasitic ones);
- •diffusive connective-tissue (autoimmune) diseases;
- •renal and hepatic failure;
- •systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolite agents by the time of inclusion into the study;
- •concomitant skin diseases: skin lymphoma, scab, lichen ruber planus, psoriasis;
- •professional activity involving skin injury, exposure to cold, insolation, ultraviolet radiation;
- •psychoses;
- •application of pre-, probiotics, antibiotics, neuroleptics or tranquilizers 2 weeks before inclusion or during participation in the study;
- •participation in other clinical study 1 month before inclusion or during participation in the proposed study.
研究组 & 干预措施
Lactofiltrum
干预措施: Lactofiltrum (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
SCORAD Index
时间窗: Day 21 after start of the intervention
The Scoring of Atopic Dermatitis (SCORAD) index is a composite index (0-100 scores) measured by blinded physician assessing three main clinical features of the disease (separate scales), namely area of lesion, clinical severity, subjective symptoms.
次要结局
- Biochemical blood analysis(Day 21 after start of the intervention)
- SCORAD Index(Day 10 after start of the intervention)
- Dermatological Index of Life Quality(Day 30 after end of the intervention)
- Urine analysis(Day 21 after start of the intervention)
- BRS Index(Day 30 after end of the intervention)
- Blood test(Day 21 after start of the intervention)