KM110329 in Adult Patients With Atopic Dermatitis | NCT01692093

Studies
KM110329 in Adult Patients With Atopic Dermatitis

NCT01692093

Sponsor

Kyunghee University Medical Center

Status

Unknown status

Last Update Posted

Nov 14, 2013Estimated

Enrollment

66Estimated

Phase

Phase 2

Conditions

Atopic Dermatitis

Interventions

KM110329
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jun 2014Estimated

Completion Date

Sep 2014Estimated

First Submitted Date

Sep 17, 2012

First Submission Date that Met QC Criteria

Sep 20, 2012

First Posted Date

Sep 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2013

Last Update Posted Date

Nov 14, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seong-Gyu Ko, Professor, Kyunghee University Medical CenterPrincipal Investigator

Lead Sponsor

Kyunghee University Medical CenterOTHER

Collaborators

Name	Class
St Mary's Hospital, London	OTHER
Chung-Ang University Hospital	OTHER
Kyung Hee University Hospital at Gangdong	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KM110329	Experimental	Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.	Dietary Supplement: KM110329
Control	Placebo Comparator	Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KM110329	Dietary Supplement	KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health	KM110329

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SCORAD index	SCORing Atopic Dermatitis	8 weeks

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
TEWL	Transepidermal Water Loss	8 weeks
hydration in the stratum corneum	hydration in the stratum corneum	8 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
SEONG GYU KO, M.D.(DKM)	Kyunghee University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Kyung Hee University	Recruiting	Seoul		130-701	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24279519	Derived	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.

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis