KM110329 in Adult Patients With Atopic Dermatitis

KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial

The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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