Usefulness and Safety of Sublingual Dermatophagoides Farinae Drops in Patients With Atopic Dermatitis:A Randomized,Double-blind,Placebo-controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 239
- 试验地点
- 1
- 主要终点
- average anesis interval
研究概览
简要总结
To assess the effect and safety of sublingual Dermatophagoides Farinae Drops in adult patients with atopic dermatitis and allergic sensitization to house dust mites.240 adults age 18 to 60 years with atopic dermatitis(Objective Scoring Atopic Dermatitis, Objective SCORAD from 10 to 40) are going to be enrolled in a randomized,double-blind,placebo-controlled study.Sublingual Dermatophagoides Farinae Drops or placebo is given for 9 months in addition to standard therapy.SCORAD,average anesis interval,rescue medicine and DLQI will be recorded.
详细描述
SCORAD is composed of skin rash area,severity and subjective symptom including pruritus and sleeping quality.Skin rash area and severity score are objective SCORAD(range from 0 to 83).Subjective SCORAD range from 0 to 20 and total SCORAD range from 0 to 103.
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
- Double (Participant, Investigator)
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 of either sex ,aged from 18 to 60 years. Diagnosed of atopic dermatitis.
- •Mild to moderate AD ( [SCORAD] 1O-40)
- •The results of skin prick tests with dermatophagoides farinae allergen extracts preparation is positive(≥2+)
- •Written informed consent by the subject or legal guardian.
- •Female patients of child-bearing potential must be negative pregnant test on screening and use an appropriate method of contraception.
排除标准
- •Dust mites are not the primary allergens.
- •Pregnant, breastfeeding women or women planned to pregnant within 1 year.
- •Have concurrent skin disease that it could interfere with the study evaluation.
- •Were treated with antihistamines or topical therapy within 7 days of randomization.
- •Have received systemic corticosteroids,leukotriene receptor antagonists or immunosuppressants within 4 weeks of randomization.
- •Have received phototherapy (e.g. UVA, UVB) within 4 weeks of randomization.
- •Have a history of immune suppressed diseases(malignant tumor or infection of HIV), autoimmune disease or tuberculosis.
- •Patients with impaired liver function (aspartate aminotransferase and/ or alanine aminotransferase levels 1.5 times the upper limit of normal), impaired renal function(serum creatinine>normal value) or other severe diseases.
- •Bronchial asthma patients who need treatments with corticosteroids and or β agonists(including injection, oral administration or inhalation) regularly.
- •Patients who need to take β-blockers during research.
- •Have received investigational drugs within 3 months prior to randomization or planned use of other investigational drugs during participation in this study.
- •Have received immunotherapy with dust mite preparation within 3 years prior to randomization.
- •Patients with severe mental disorders.
研究组 & 干预措施
Dermatophagoides Farinae Drops Group 1
Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.
干预措施: Dermatophagoides Farinae Drops Group 1 (Biological)
Dermatophagoides Farinae Drops Group 2
Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drops of placebo.
干预措施: Dermatophagoides Farinae Drops Group 2 (Biological)
Dermatophagoides Farinae Drops Group 3
Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
干预措施: Dermatophagoides Farinae Drops Group 3 (Biological)
Placebo
Placebo Group is the group with maintenance dose of 3 drops of placebo.
干预措施: Placebo (Biological)
结局指标
主要结局
average anesis interval
时间窗: baseline and 36 week
The average duration of last 3 whole anesis interval.
Rescue medication consumption
时间窗: 36 week
The total sum of rescue medication consumption will be recorded.
SCORAD
时间窗: baseline and 36 week
Change of SCORAD will be assessed.
次要结局
- DLQI(baseline and 36 week)
研究者
Min Zheng
Director of dermatology department,Professor
Zhejiang University