<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/NCT04456829</url>
  </required_header>
  <id_info>
    <org_study_id>20-0-54-B</org_study_id>
    <nct_id>NCT04456829</nct_id>
  </id_info>
  <brief_title>Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin Conditions and Inflammatory Related Factors</brief_title>
  <acronym>Resveratrol</acronym>
  <official_title>Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TCI Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TCI Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess a resveratrol formula on improvement of skin conditions and inflammatory cytokines&#xD;
      in blood&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 17, 2020</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">November 10, 2020</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of skin moisture</measure>
    <time_frame>0, 4, and 8 weeks</time_frame>
    <description>Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of skin elasticity</measure>
    <time_frame>0, 4, and 8 weeks</time_frame>
    <description>Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of skin wrinkles</measure>
    <time_frame>0, 4, and 8 weeks</time_frame>
    <description>VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of skin collagen density</measure>
    <time_frame>0, 4, and 8 weeks</time_frame>
    <description>DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:&#xD;
Intensity score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of skin texture</measure>
    <time_frame>0, 4, and 8 weeks</time_frame>
    <description>VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of skin pores</measure>
    <time_frame>0, 4, and 8 weeks</time_frame>
    <description>VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of total antioxidant capacity of blood</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>Total Antioxidant Capacity Assay Kit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of TNF-alpha of blood</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>ELISA Kit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of IL-6 of blood</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>ELISA Kit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of IL-17 of blood</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>ELISA Kit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change of IL-1β of blood</measure>
    <time_frame>0 and 8 weeks</time_frame>
    <description>ELISA Kit</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Skin Conditions</condition>
  <condition>Proinflammatory Cytokines</condition>
  <arm_group>
    <arm_group_label>Resveratrol drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo drink</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Resveratrol drink</intervention_name>
    <description>Subjects will consume a bottle of resveratrol drink for two months.</description>
    <arm_group_label>Resveratrol drink</arm_group_label>
    <other_name>Grape Yeast Compound Fruit Vegetable Beverage</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo drink</intervention_name>
    <description>Subjects will consume a bottle of placebo drink for two months.</description>
    <arm_group_label>Placebo drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers aged above 20 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject who is not willing to participate in this study.&#xD;
&#xD;
          -  Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs&#xD;
             and patients with mental illness (according to medical history).&#xD;
&#xD;
          -  Subjects who have known cosmetic, drug or food allergies, difficulty in digestive&#xD;
             tract absorption or disorder.&#xD;
&#xD;
          -  Female who is pregnant or nursing or planning to become pregnant during the course of&#xD;
             the study.&#xD;
&#xD;
          -  Received facial laser therapy, chemical peeling or UV overexposure in the past 4&#xD;
             weeks.&#xD;
&#xD;
          -  Subjects who have large spots (area &gt;3 square centimeter) or abnormal acne.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chia Nan University of Pharmacy &amp; Science</name>
      <address>
        <city>Tainan City</city>
        <zip>71710</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Diseases</mesh_term>
    <mesh_term>Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Resveratrol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04456829
org study id: 20-0-54-B
nct id: NCT04456829
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess a resveratrol formula on improvement of skin conditions and inflammatory cytokines
      in blood
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: The change of skin moisture
time frame: 0, 4, and 8 weeks
description: Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
measure: The change of skin elasticity
time frame: 0, 4, and 8 weeks
description: Cutometer® dual MPA 580 was utilized to measure skin elasticity (parameter R2). Units: μm penetration depth into the probe opening, expressed as curves
measure: The change of skin wrinkles
time frame: 0, 4, and 8 weeks
description: VISIA Complexion Analysis System was utilized to measure wrinkles. Units: arbitrary units
measure: The change of skin collagen density
time frame: 0, 4, and 8 weeks
description: DermaLab® USB - 20 MHz High Freq. Ultrasound probe was utilized to scan and analyze skin collagen density. Units:
Intensity score
measure: The change of skin texture
time frame: 0, 4, and 8 weeks
description: VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
measure: The change of skin pores
time frame: 0, 4, and 8 weeks
description: VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
measure: The change of total antioxidant capacity of blood
time frame: 0 and 8 weeks
description: Total Antioxidant Capacity Assay Kit
measure: The change of TNF-alpha of blood
time frame: 0 and 8 weeks
description: ELISA Kit
measure: The change of IL-6 of blood
time frame: 0 and 8 weeks
description: ELISA Kit
measure: The change of IL-17 of blood
time frame: 0 and 8 weeks
description: ELISA Kit
measure: The change of IL-1β of blood
time frame: 0 and 8 weeks
description: ELISA Kit
arm group label: Resveratrol drink
arm group type: Experimental
arm group label: Placebo drink
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Resveratrol drink
description: Subjects will consume a bottle of resveratrol drink for two months.
arm group label: Resveratrol drink
other name: Grape Yeast Compound Fruit Vegetable Beverage
intervention type: Dietary Supplement
intervention name: Placebo drink
description: Subjects will consume a bottle of placebo drink for two months.
arm group label: Placebo drink
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Skin Diseases
mesh term: Disease
mesh term: Resveratrol
sharing ipd: No