<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/NCT02257281</url>
  </required_header>
  <id_info>
    <org_study_id>CS14008</org_study_id>
    <nct_id>NCT02257281</nct_id>
  </id_info>
  <brief_title>The Effect of Therapeutic Ultrasound on Soft Tissue: An Experimentally-induced Skin Model</brief_title>
  <official_title>Chung Shan Medical University Hospital Institutional Review Board</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chung Shan Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chung Shan Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of study are to investigate the effect of therapeutic ultrasound for the&#xD;
      inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on&#xD;
      different inflammatory level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Therapeutic ultrasound for soft tissue repair has been used in clinical during the past&#xD;
      decades. In some recent systematic review, the evidence of clinical trials were&#xD;
      insufficiency. We assumed the reaserch biasin clinical trials may be due to the different&#xD;
      inflammatory level of soft tissue under the similar ultrasound intensity. Our purpose of&#xD;
      study is to investigate the effect of therapeutic ultrasound for the inflammatory skin repair&#xD;
      and whether the tissue repair under ultrasound treament is depend on different inflammatory&#xD;
      level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>skin blood flow</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>skin temperature</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin water content</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tactile pain threshold</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>erythema index</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>skin thickness</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Active Therapeutic Ultrasound</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The three inflammatory forearm spots on the same side induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with active therapeutic ultrasound .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-active Therapeutic Ultrasound</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Therapeutic Ultrasound</intervention_name>
    <description>For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.</description>
    <arm_group_label>Active Therapeutic Ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Non-active Therapeutic Ultrasound</intervention_name>
    <description>For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.</description>
    <arm_group_label>Non-active Therapeutic Ultrasound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. asia healthy subjects&#xD;
&#xD;
          2. aged 20-45 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. disadvantaged groups&#xD;
&#xD;
          2. systemic disease, such as DM, cancer, autoimmune disorder&#xD;
&#xD;
          3. hyperhidrosis or hypothyroidism&#xD;
&#xD;
          4. a past history of dermatitis&#xD;
&#xD;
          5. active infective or inflammatory cutaneous disease&#xD;
&#xD;
          6. smoking or drinking&#xD;
&#xD;
          7. take medicine, over sun exposure, exercise or menstruation during experimental period&#xD;
&#xD;
          8. contraindication of therapeutic ultrasound&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peir Renn Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of rehabilitation</affiliation>
  </overall_official>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>December 13, 2015</last_update_submitted>
  <last_update_submitted_qc>December 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chung Shan Medical University</investigator_affiliation>
    <investigator_full_name>GCRC</investigator_full_name>
    <investigator_title>Chung Shan Medical University</investigator_title>
  </responsible_party>
  <keyword>Sodium lauryl sulfate</keyword>
  <keyword>Skin irritants</keyword>
  <keyword>inflammation</keyword>
  <keyword>therapeutic ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 11, 2018</submitted>
    <returned>May 11, 2018</returned>
  </pending_results>
  <!-- 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/NCT02257281
org study id: CS14008
nct id: NCT02257281
lead sponsor: 
has dmc: No
The purposes of study are to investigate the effect of therapeutic ultrasound for the
      inflammatory skin repair and whether the tissue repair under ultrasound treament is depend on
      different inflammatory level.
Therapeutic ultrasound for soft tissue repair has been used in clinical during the past
      decades. In some recent systematic review, the evidence of clinical trials were
      insufficiency. We assumed the reaserch biasin clinical trials may be due to the different
      inflammatory level of soft tissue under the similar ultrasound intensity. Our purpose of
      study is to investigate the effect of therapeutic ultrasound for the inflammatory skin repair
      and whether the tissue repair under ultrasound treament is depend on different inflammatory
      level.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: skin blood flow
time frame: 2 weeks
measure: skin temperature
time frame: 2 weeks
measure: skin water content
time frame: 2 weeks
measure: Tactile pain threshold
time frame: 2 weeks
measure: erythema index
time frame: 2 weeks
measure: skin thickness
time frame: 2 weeks
arm group label: Active Therapeutic Ultrasound
arm group type: Experimental
description: The three inflammatory forearm spots on the same side induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with active therapeutic ultrasound .
arm group label: Non-active Therapeutic Ultrasound
arm group type: Placebo Comparator
description: The contralateral three inflammatory forearm spots induce by the experimentally skin model(1%, 0.5%, 0% SLS) treat with non-active therapeutic ultrasound .
intervention type: Device
intervention name: Active Therapeutic Ultrasound
description: For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.
arm group label: Active Therapeutic Ultrasound
intervention type: Device
intervention name: Non-active Therapeutic Ultrasound
description: For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.
arm group label: Non-active Therapeutic Ultrasound
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peir Renn Wang, MD
role: Principal Investigator
affiliation: Department of rehabilitation
responsible party type: Principal Investigator
investigator affiliation: Chung Shan Medical University
investigator full name: GCRC
investigator title: Chung Shan Medical University
mesh term: Inflammation
submitted: April 11, 2018
returned: May 11, 2018