KM110329 in Adult Patients With Atopic Dermatitis

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

Detailed Description
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: KM110329
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KM110329<br>Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals. | Dietary Supplement: KM110329<br>* KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health<br>|
| Placebo Comparator: Control<br>Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals. | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCORAD index | SCORing Atopic Dermatitis | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLQI | The Dermatology Life Quality Index | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCORAD, Atopic dermatits, Skin health