Clinical trial NCT01692093: KM110329 in Adult Patients With Atopic Dermatitis
Official title: KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: SCORAD
Atopic dermatits
Skin health
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: St Mary's Hospital, London
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Kyung Hee University Hospital at Gangdong
First posted: 2012-09-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: SCORAD index
timeFrame: 8 weeks
Secondary outcomes:
measure: DLQI
timeFrame: 8 weeks
Other outcomes:
measure: TEWL
timeFrame: 8 weeks
measure: hydration in the stratum corneum
timeFrame: 8 weeks
measure: KiFDA-HM-AD
timeFrame: 8 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University
Study officials:
affiliation: Kyunghee University
name: SEONG GYU KO, M.D.(DKM)
role: STUDY_DIRECTOR
References:
citation: Cheon C, Park S, Park JS, Oh SM, Jang S, Go HY, Jang BH, Shin YC, Ko SG. KM110329 in adult patients with atopic dermatitis: a randomised, double-blind, placebo-controlled, multicentre trial--study protocol. BMC Complement Altern Med. 2013 Nov 27;13:335. doi: 10.1186/1472-6882-13-335.