KM110329 in Adult Patients With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01692093
• Other study ID #: CCRG_KM110329
• Status: Recruiting
• Phase: Phase 2
• First received: September 17, 2012
• Last updated: November 12, 2013
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: November 2013
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• KM110329
KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
• Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Chung-Ang University Hospital, Kyung Hee University Hospital at Gangdong, St Mary's Hospital, London

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	TEWL	Transepidermal Water Loss	8 weeks	No
Other	hydration in the stratum corneum	hydration in the stratum corneum	8 weeks	No
Other	KiFDA-HM-AD	Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis	8 weeks	No
Primary	SCORAD index	SCORing Atopic Dermatitis	8 weeks	No
Secondary	DLQI	The Dermatology Life Quality Index	8 weeks	No