<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01692093</url>
  </required_header>
  <id_info>
    <org_study_id>CCRG_KM110329</org_study_id>
    <nct_id>NCT01692093</nct_id>
  </id_info>
  <brief_title>KM110329 in Adult Patients With Atopic Dermatitis</brief_title>
  <official_title>KM110329 in Adult Patients With Atopic Dermatitis : a Randomised, Double-blind, Placebo-controlled, Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyunghee University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St Mary's Hospital, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chung-Ang University Hosptial, Chung-Ang University College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kyung Hee University Hospital at Gangdong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kyunghee University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic&#xD;
      dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double blind, placebo-controlled, multicenter trial will be conducted at the&#xD;
      Seoul St.Mary's Hospital, at Chung-ang University hospital, and at Kyung Hee University&#xD;
      Hospital at Gangdong.&#xD;
&#xD;
      Participants fulfilling eligibility criteria will be selected. Enrolled participants will be&#xD;
      randomly allocated to two parallel groups: the KM110329 and placebo arms.&#xD;
&#xD;
      Each participant will be examined for signs and symptoms of Atopic dermatitis before and&#xD;
      after taking functional food.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2014</completion_date>
  <primary_completion_date type="Anticipated">June 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SCORAD index</measure>
    <time_frame>8 weeks</time_frame>
    <description>SCORing Atopic Dermatitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DLQI</measure>
    <time_frame>8 weeks</time_frame>
    <description>The Dermatology Life Quality Index</description>
  </secondary_outcome>
  <other_outcome>
    <measure>TEWL</measure>
    <time_frame>8 weeks</time_frame>
    <description>Transepidermal Water Loss</description>
  </other_outcome>
  <other_outcome>
    <measure>hydration in the stratum corneum</measure>
    <time_frame>8 weeks</time_frame>
    <description>hydration in the stratum corneum</description>
  </other_outcome>
  <other_outcome>
    <measure>KiFDA-HM-AD</measure>
    <time_frame>8 weeks</time_frame>
    <description>Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>KM110329</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo drug for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>KM110329</intervention_name>
    <description>KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health</description>
    <arm_group_label>KM110329</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women ages 18 to 65 years&#xD;
&#xD;
          -  Individuals who diagnosed Atopic dermatitis according to the criteria of Hanifin and&#xD;
             Rajka&#xD;
&#xD;
          -  Individuals who mild to moderate atopic dermatitis (objective SCORAD≤40)&#xD;
&#xD;
          -  Written informed consent for participation in the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe skin disease other than Atopic dermatitis&#xD;
&#xD;
          -  Secondary infection with bacteria, fungi, and virus&#xD;
&#xD;
          -  Uncontrolled hypertension (SBP &gt; 145 mmHg or DBP &gt; 95 mmHg)&#xD;
&#xD;
          -  Severe liver disability (2.5-fold the normal high range value for ALT, AST)&#xD;
&#xD;
          -  Severe renal disability (sCr &gt; 2.0mg/dl)&#xD;
&#xD;
          -  Women who are pregnant, lactating, planning a pregnancy or women of child-bearing age&#xD;
             who do not agree to proper contraception&#xD;
&#xD;
          -  Use of oral steroids, oral antibiotic or other immunosuppressants within the past 4&#xD;
             weeks&#xD;
&#xD;
          -  Treated by systemic photochemotherapy within past 4 weeks&#xD;
&#xD;
          -  History of drug abuse&#xD;
&#xD;
          -  Hypersensitivity to Rubi Fructus, Houttuyniae Herba, Rehmanniae Radix, Betulae&#xD;
             Platyphyllae Cortex&#xD;
&#xD;
          -  Use of other investigational products within the past two months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>SEONG GYU KO, M.D.(DKM)</last_name>
    <role>Study Director</role>
    <affiliation>Kyunghee University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyung Hee University</name>
      <address>
        <city>Seoul</city>
        <zip>130-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHUNHOO CHEON, M.D.(DKM)</last_name>
      <phone>82-2-961-9278</phone>
      <email>pm.thehoo@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>November 12, 2013</last_update_submitted>
  <last_update_submitted_qc>November 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyunghee University Medical Center</investigator_affiliation>
    <investigator_full_name>Seong-Gyu Ko</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>SCORAD</keyword>
  <keyword>Atopic dermatits</keyword>
  <keyword>Skin health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01692093
org study id: CCRG_KM110329
nct id: NCT01692093
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine clinical efficacy and safety of KM110329 for Atopic
      dermatitis.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: SCORAD index
time frame: 8 weeks
description: SCORing Atopic Dermatitis
measure: DLQI
time frame: 8 weeks
description: The Dermatology Life Quality Index
measure: TEWL
time frame: 8 weeks
description: Transepidermal Water Loss
measure: hydration in the stratum corneum
time frame: 8 weeks
description: hydration in the stratum corneum
measure: KiFDA-HM-AD
time frame: 8 weeks
description: Evaluation endpoint for clinical trial of herbal medicinal products about atopic dermatitis
arm group label: KM110329
arm group type: Experimental
description: Participants will receive KM110329 for eight weeks. Participants will take 2 tablets by mouth with water two times a day after meals.
arm group label: Control
arm group type: Placebo Comparator
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: KM110329
description: KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
arm group label: KM110329
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: SEONG GYU KO, M.D.(DKM)
role: Study Director
affiliation: Kyunghee University
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Kyunghee University Medical Center
investigator full name: Seong-Gyu Ko
investigator title: Professor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema