KM110329 in Adult Patients With Atopic Dermatitis

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01692093

Enrollment

Registered

2012-09-25

Start date

2012-09-30

Completion date

2014-09-30

Last updated

2013-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

SCORAD, Atopic dermatits, Skin health

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.

Interventions

DIETARY_SUPPLEMENTKM110329

KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health

DIETARY_SUPPLEMENTPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
SCORAD index	8 weeks	SCORing Atopic Dermatitis

Secondary

Measure	Time frame	Description
DLQI	8 weeks	The Dermatology Life Quality Index

Other

Measure	Time frame	Description
TEWL	8 weeks	Transepidermal Water Loss
hydration in the stratum corneum	8 weeks	hydration in the stratum corneum
KiFDA-HM-AD	8 weeks	Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026