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KM110329 in Adult Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01692093
Recruitment Status : Unknown
Verified November 2013 by Seong-Gyu Ko, Kyunghee University Medical Center.
Recruitment status was:  Recruiting
First Posted : September 25, 2012
Last Update Posted : November 14, 2013
Sponsor:
Collaborators:
St Mary's Hospital, London
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Kyung Hee University Hospital at Gangdong
Information provided by (Responsible Party):
Seong-Gyu Ko, Kyunghee University Medical Center

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

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Dietary Supplement: KM110329 Dietary Supplement: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial
Study Start Date : September 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. SCORAD index [ Time Frame: 8 weeks ]
    SCORing Atopic Dermatitis


Secondary Outcome Measures :
  1. DLQI [ Time Frame: 8 weeks ]
    The Dermatology Life Quality Index


Other Outcome Measures:
  1. TEWL [ Time Frame: 8 weeks ]
    Transepidermal Water Loss

  2. hydration in the stratum corneum [ Time Frame: 8 weeks ]
    hydration in the stratum corneum

  3. KiFDA-HM-AD [ Time Frame: 8 weeks ]
    Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hosptial, Chung-Ang University College of Medicine
Kyung Hee University Hospital at Gangdong
Investigators
Study Director: SEONG GYU KO, M.D.(DKM) Kyunghee University

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
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013

Keywords provided by Seong-Gyu Ko, Kyunghee University Medical Center:
SCORAD
Atopic dermatits
Skin health

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