KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- SCORAD index
研究概览
简要总结
The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis.
详细描述
A randomized, double blind, placebo-controlled, multicenter trial will be conducted at the Seoul St.Mary's Hospital, at Chung-ang University hospital, and at Kyung Hee University Hospital at Gangdong.
Participants fulfilling eligibility criteria will be selected. Enrolled participants will be randomly allocated to two parallel groups: the KM110329 and placebo arms.
Each participant will be examined for signs and symptoms of Atopic dermatitis before and after taking functional food.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ages 18 to 65 years
- •Individuals who diagnosed Atopic dermatitis according to the criteria of Hanifin and Rajka
- •Individuals who mild to moderate atopic dermatitis (objective SCORAD≤40)
- •Written informed consent for participation in the trial
排除标准
- •Severe skin disease other than Atopic dermatitis
- •Secondary infection with bacteria, fungi, and virus
- •Uncontrolled hypertension (SBP > 145 mmHg or DBP > 95 mmHg)
- •Severe liver disability (2.5-fold the normal high range value for ALT, AST)
- •Severe renal disability (sCr > 2.0mg/dl)
- •Women who are pregnant, lactating, planning a pregnancy or women of child-bearing age who do not agree to proper contraception
- •Use of oral steroids, oral antibiotic or other immunosuppressants within the past 4 weeks
- •Treated by systemic photochemotherapy within past 4 weeks
- •History of drug abuse
- •Hypersensitivity to Rubi Fructus, Houttuyniae Herba, Rehmanniae Radix, Betulae Platyphyllae Cortex
- •Use of other investigational products within the past two months
研究组 & 干预措施
KM110329
Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
干预措施: KM110329 (Dietary Supplement)
Control
Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
SCORAD index
时间窗: 8 weeks
SCORing Atopic Dermatitis
次要结局
- DLQI(8 weeks)
研究者
Seong-Gyu Ko
Professor
Kyunghee University Medical Center