KM110329 in Adult Patients With Atopic Dermatitis

This study is currently recruiting participants.
Verified November 2013 by Kyunghee University Medical Center
Sponsor:
Collaborators:
St. Mary's Hospital
Chung-Ang University Hospital
Kyung Hee University Gangdong Hospital
Information provided by (Responsible Party):
Seong-Gyu Ko, Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01692093
First received: September 17, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
Dietary Supplement: KM110329
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • SCORAD index [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    SCORing Atopic Dermatitis


Secondary Outcome Measures:
  • DLQI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The Dermatology Life Quality Index


Other Outcome Measures:
  • TEWL [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Transepidermal Water Loss

  • hydration in the stratum corneum [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    hydration in the stratum corneum

  • KiFDA-HM-AD [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis


Estimated Enrollment: 66
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KM110329
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
KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
Placebo Comparator: Control
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
Placebo

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01692093

Locations
Korea, Republic of
Kyung Hee University Recruiting
Seoul, Korea, Republic of, 130-701
Contact: CHUNHOO CHEON, M.D.(DKM)    82-2-961-9278    pm.thehoo@gmail.com   
Sponsors and Collaborators
Kyunghee University Medical Center
St. Mary's Hospital
Chung-Ang University Hospital
Kyung Hee University Gangdong Hospital
Investigators
Study Director: SEONG GYU KO, M.D.(DKM) Kyung Hee University
  More Information

No publications provided by Kyunghee University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seong-Gyu Ko, Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01692093     History of Changes
Other Study ID Numbers: CCRG_KM110329
Study First Received: September 17, 2012
Last Updated: November 12, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Kyunghee University Medical Center:
SCORAD
Atopic dermatits
Skin health

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014