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KM110329 in Adult Patients With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KM110329
Placebo
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring SCORAD, Atopic dermatits, Skin health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kyung Hee UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KM110329

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

SCORAD index
SCORing Atopic Dermatitis

Secondary Outcome Measures

DLQI
The Dermatology Life Quality Index

Full Information

First Posted
September 17, 2012
Last Updated
November 12, 2013
Sponsor
Kyunghee University Medical Center
Collaborators
St Mary's Hospital, London, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT01692093
Brief Title
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

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
St Mary's Hospital, London, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Kyung Hee University Hospital at Gangdong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
SCORAD, Atopic dermatits, Skin health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KM110329
Arm Type
Experimental
Arm Description
Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
Intervention Type
Dietary Supplement
Intervention Name(s)
KM110329
Intervention Description
KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
SCORAD index
Description
SCORing Atopic Dermatitis
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
DLQI
Description
The Dermatology Life Quality Index
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
TEWL
Description
Transepidermal Water Loss
Time Frame
8 weeks
Title
hydration in the stratum corneum
Description
hydration in the stratum corneum
Time Frame
8 weeks
Title
KiFDA-HM-AD
Description
Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SEONG GYU KO, M.D.(DKM)
Organizational Affiliation
Kyunghee University
Official's Role
Study Director
Facility Information:
Facility Name
Kyung Hee University
City
Seoul
ZIP/Postal Code
130-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHUNHOO CHEON, M.D.(DKM)
Phone
82-2-961-9278
Email
pm.thehoo@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24279519
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.
Results Reference
derived

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KM110329 in Adult Patients With Atopic Dermatitis

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