KM110329 in Adult Patients With Atopic Dermatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Kyunghee University Medical Center
Sponsor:
Collaborators:
St Mary's Hospital, London
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, London
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 October 19, 2014