KM110329 in Adult Patients With Atopic Dermatitis

Phase 2

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: KM110329; Dietary Supplement: Placebo

• Registration Number: NCT01692093
• Lead Sponsor: Kyunghee University Medical Center

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-09-20
• Study First Posted: 2012-09-25
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-14
• Primary Completion: 2014-06
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KM110329	KM110329	Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
Control	Placebo	Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.

Primary Outcome Measures

Name	Time	Method
SCORAD index	8 weeks	SCORing Atopic Dermatitis

Secondary Outcome Measures

Name	Time	Method
DLQI	8 weeks	The Dermatology Life Quality Index

Trial Locations

Locations (1)

Kyung Hee University; 🇰🇷 Seoul, Korea, Republic of