<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/NCT03246776</url>
  </required_header>
  <id_info>
    <org_study_id>BeijingFH20170801</org_study_id>
    <nct_id>NCT03246776</nct_id>
  </id_info>
  <brief_title>Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan</brief_title>
  <acronym>MCCK</acronym>
  <official_title>The Clinical Study of the Microbial Colonization of Chronic Keratinized Hand Eczema and the Change of Microbial Colonization After External Using of Halometasone Triclosan Cream</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Friendship Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical study of the microbial colonization of chronic keratinized hand eczema and the&#xD;
      change of microbial colonization after external using of Halometasone Triclosan Cream&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The clinical study of the microbial colonization of chronic keratinized hand eczema and the&#xD;
      change of microbial colonization after external using of Halometasone Triclosan Cream&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Actual">December 8, 2017</completion_date>
  <primary_completion_date type="Actual">December 8, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Response to Hand eczema severity</measure>
    <time_frame>2 weeks</time_frame>
    <description>HEES(hand eczema extent score)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response to treatment/Hand eczema severity</measure>
    <time_frame>2 weeks</time_frame>
    <description>Photographic evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator reported improvement</measure>
    <time_frame>2 weeks</time_frame>
    <description>IGA(investigator's global assessment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to treatment/Hand eczema severity</measure>
    <time_frame>2 weeks</time_frame>
    <description>Dermatoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to Quality of Life</measure>
    <time_frame>week 0 and 2</time_frame>
    <description>questionnaire :DLQI(dermatology life quality index)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Improvement</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>VAS(Visual Analog Score for pruritus)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to treatment/Hand eczema severity</measure>
    <time_frame>2 weeks</time_frame>
    <description>HECSI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response to Microbial Colonization rates</measure>
    <time_frame>2 weeks</time_frame>
    <description>Staphylococcus aureus colonization rates</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Chronic Hand Eczema</condition>
  <arm_group>
    <arm_group_label>Halometasone Triclosan Cream</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects receive external Use of Halometasone Triclosan Cream</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Halometasone Triclosan</intervention_name>
    <description>Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment</description>
    <arm_group_label>Halometasone Triclosan Cream</arm_group_label>
    <other_name>regular moisturizer</other_name>
    <other_name>wet wrap bandage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Chronic Keratinized hand eczema for at least 3 months&#xD;
&#xD;
          -  The affected area is greater than 30%&#xD;
&#xD;
          -  Overall assessment of the severity of the disease(IGA)≥3 OR HEES≥13&#xD;
&#xD;
          -  No obvious incentive .Who have read the instructions of the subject, agreed to and&#xD;
             signed written informed consent, and have been able to provide a personal medical&#xD;
             history.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy, breast feeding&#xD;
&#xD;
          -  Severe liver and kidney disease, blood system disease, autoimmune disease, chronic&#xD;
             severe infection, diabetes, mental illness, drug use, alcohol abuse, etc&#xD;
&#xD;
          -  Malignant neoplasms or other serious maladies that may affect the correct assessment&#xD;
             of efficacy&#xD;
&#xD;
          -  Topical corticosteroid was suspended for less than 2 weeks;The system used&#xD;
             corticosteroids and other immunosuppressive agents (thunder vine and other drugs)&#xD;
             which were suspended for less than four weeks&#xD;
&#xD;
          -  Eczema of the facial and skin creases&#xD;
&#xD;
          -  Atopic dermatitis, contact dermatitis, blister hand eczema, contact urticaria, discoid&#xD;
             eczema&#xD;
&#xD;
          -  participated in other clinical trials within 3 months.&#xD;
&#xD;
          -  Known sensitivity to Halometasone Triclosan&#xD;
&#xD;
          -  failure to follow the prescribed medication or the incomplete record of the test&#xD;
             process which will affect the curative effect judgment&#xD;
&#xD;
          -  Other reasons why researchers think they should not be included&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>linfeng li, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>January 26, 2018</last_update_submitted>
  <last_update_submitted_qc>January 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Wei Xu</investigator_full_name>
    <investigator_title>associated professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triclosan</mesh_term>
    <mesh_term>Halometasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03246776
org study id: BeijingFH20170801
nct id: NCT03246776
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The clinical study of the microbial colonization of chronic keratinized hand eczema and the
      change of microbial colonization after external using of Halometasone Triclosan Cream
The clinical study of the microbial colonization of chronic keratinized hand eczema and the
      change of microbial colonization after external using of Halometasone Triclosan Cream
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: open label
measure: Response to Hand eczema severity
time frame: 2 weeks
description: HEES(hand eczema extent score)
measure: Response to treatment/Hand eczema severity
time frame: 2 weeks
description: Photographic evaluation
measure: Investigator reported improvement
time frame: 2 weeks
description: IGA(investigator's global assessment)
measure: Response to treatment/Hand eczema severity
time frame: 2 weeks
description: Dermatoscopy
measure: Response to Quality of Life
time frame: week 0 and 2
description: questionnaire :DLQI(dermatology life quality index)
measure: Patient Reported Improvement
time frame: up to 2 weeks
description: VAS(Visual Analog Score for pruritus)
measure: Response to treatment/Hand eczema severity
time frame: 2 weeks
description: HECSI
measure: Response to Microbial Colonization rates
time frame: 2 weeks
description: Staphylococcus aureus colonization rates
arm group label: Halometasone Triclosan Cream
arm group type: Experimental
description: All subjects receive external Use of Halometasone Triclosan Cream
intervention type: Drug
intervention name: Halometasone Triclosan
description: Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment
arm group label: Halometasone Triclosan Cream
other name: regular moisturizer
other name: wet wrap bandage
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: linfeng li, phd
role: Principal Investigator
affiliation: Beijing Friendship Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Friendship Hospital
investigator full name: Wei Xu
investigator title: associated professor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Eczema
mesh term: Triclosan
mesh term: Halometasone
sharing ipd: Undecided