KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- SCORAD index
Study Overview
Brief Summary
The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic dermatitis.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
KM110329
Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
Intervention: 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.
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
SCORAD index
Time Frame: 8 weeks
SCORing Atopic Dermatitis
Secondary Outcomes
- DLQI(8 weeks)
Investigators
Seong-Gyu Ko
Professor
Kyunghee University Medical Center