KM110329 in Adult Patients With Atopic Dermatitis

Kyung Hee University

Status and phase: Unknown; Phase 2

Conditions: Atopic Dermatitis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: KM110329

Study type: Interventional

Funder types: Other

Identifiers

NCT01692093

CCRG_KM110329

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

KM110329

Experimental group

Description:

Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.

Treatment:

Dietary Supplement: KM110329

Control

Placebo Comparator group

Description:

Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.

Treatment:

Dietary Supplement: Placebo