xml: <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/NCT05988567</url>
    </required_header>
    <id_info>
      <org_study_id>23-049-B</org_study_id>
      <nct_id>NCT05988567</nct_id>
    </id_info>
    <brief_title>Efficacy Testing of Melon Oil Olive Pressed Candy Products</brief_title>
    <official_title>Efficacy Testing of Melon Oil Olive Pressed Candy Products</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>
      <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 melon and oil olive pressed candy on skin condition improvement&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">May 9, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The change of skin wrinkles</measure>
      <time_frame>Change from Baseline skin wrinkles at 12 weeks</time_frame>
      <description>VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin texture</measure>
      <time_frame>Change from Baseline skin texture at 12 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 melanin index</measure>
      <time_frame>Change from Baseline skin melanin index at 12 weeks</time_frame>
      <description>Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin erythema index</measure>
      <time_frame>Change from Baseline skin erythema index at 12 weeks</time_frame>
      <description>Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin L* value</measure>
      <time_frame>Change from Baseline L* value at 12 weeks</time_frame>
      <description>Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin b* value</measure>
      <time_frame>Change from Baseline b* value at 12 weeks</time_frame>
      <description>Chroma Meter MM500 was utilized to measure skin b* value. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin ITA° value</measure>
      <time_frame>Change from Baseline ITA° value at 12 weeks</time_frame>
      <description>Chroma Meter MM500 was utilized to measure skin ITA° value. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin spots</measure>
      <time_frame>Change from Baseline skin spots at 12 weeks</time_frame>
      <description>VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin UV spots</measure>
      <time_frame>Change from Baseline skin UV spots at 12 weeks</time_frame>
      <description>VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin brown spots</measure>
      <time_frame>Change from Baseline skin brown spots at 12 weeks</time_frame>
      <description>VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The change of TEAC of blood</measure>
      <time_frame>Change from Baseline TEAC at 12 weeks</time_frame>
      <description>Venous blood was sampled to measure TEAC</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of SOD of blood</measure>
      <time_frame>Change from Baseline SOD at 12 weeks</time_frame>
      <description>Venous blood was sampled to measure SOD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of GSH-Px of blood</measure>
      <time_frame>Change from Baseline GSH-Px at 12 weeks</time_frame>
      <description>Venous blood was sampled to measure GSH-Px</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The change of self-assessment skin and hair condition</measure>
      <time_frame>Change from Baseline skin and hair condition at 12 weeks</time_frame>
      <description>A self-assessment questionnaire was collected to evaluate skin and hair condition</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Skin Condition</condition>
    <arm_group>
      <arm_group_label>Placebo candy</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>melon and oil olive pressed candy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo candy</intervention_name>
      <description>consume 2 tablets per day</description>
      <arm_group_label>Placebo candy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>melon and oil olive pressed candy</intervention_name>
      <description>consume 2 tablets per day</description>
      <arm_group_label>melon and oil olive pressed candy</arm_group_label>
      <other_name>Melon, oil olive and pomegranate blend pressed candy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy adults aged 25-55 years old&#xD;
  &#xD;
            -  ITA° value 20°-41°&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Involuntary subjects.&#xD;
  &#xD;
            -  Subjects who have a history of skin diseases such as psoriasis, eczema, atopic&#xD;
               dermatitis, severe acne; or suffer from other chronic systemic disease.&#xD;
  &#xD;
            -  Those with known cosmetic, drug or food allergies.&#xD;
  &#xD;
            -  Female who is pregnant or nursing or planning to become pregnant during the course of&#xD;
               the study.&#xD;
  &#xD;
            -  Subjects who have taken oral or topical corticosteroids and other anti-inflammatory&#xD;
               drugs in the past 1 month.&#xD;
  &#xD;
            -  Use of any products or drugs that affect skin color such as fruit acid, salicylic acid&#xD;
               (such as Hydroquinone preparations) in the past 2 months.&#xD;
  &#xD;
            -  In the past 3 months, the test site has used retinoic acid preparations or undergone&#xD;
               chemical peeling, laser, pulse light and other medical aesthetic therapists&#xD;
  &#xD;
            -  Subjects who can not avoid long-term sun exposure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chia-Hua Liang, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chia Nan University of Pharmacy ＆ Science</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Chia Nan University of Pharmacy &amp; Science</name>
        <address>
          <city>Tainan City</city>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</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>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988567
  org study id: 23-049-B
  nct id: NCT05988567
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To assess melon and oil olive pressed candy on skin condition improvement
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: The change of skin wrinkles
  time frame: Change from Baseline skin wrinkles at 12 weeks
  description: VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
  measure: The change of skin texture
  time frame: Change from Baseline skin texture at 12 weeks
  description: VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
  measure: The change of skin melanin index
  time frame: Change from Baseline skin melanin index at 12 weeks
  description: Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
  measure: The change of skin erythema index
  time frame: Change from Baseline skin erythema index at 12 weeks
  description: Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units
  measure: The change of skin L* value
  time frame: Change from Baseline L* value at 12 weeks
  description: Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units
  measure: The change of skin b* value
  time frame: Change from Baseline b* value at 12 weeks
  description: Chroma Meter MM500 was utilized to measure skin b* value. Units: arbitrary units
  measure: The change of skin ITA° value
  time frame: Change from Baseline ITA° value at 12 weeks
  description: Chroma Meter MM500 was utilized to measure skin ITA° value. Units: arbitrary units
  measure: The change of skin spots
  time frame: Change from Baseline skin spots at 12 weeks
  description: VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
  measure: The change of skin UV spots
  time frame: Change from Baseline skin UV spots at 12 weeks
  description: VISIA Complexion Analysis System was utilized to measure skin UV spots. Units: arbitrary units
  measure: The change of skin brown spots
  time frame: Change from Baseline skin brown spots at 12 weeks
  description: VISIA Complexion Analysis System was utilized to measure skin brown spots. Units: arbitrary units
  measure: The change of TEAC of blood
  time frame: Change from Baseline TEAC at 12 weeks
  description: Venous blood was sampled to measure TEAC
  measure: The change of SOD of blood
  time frame: Change from Baseline SOD at 12 weeks
  description: Venous blood was sampled to measure SOD
  measure: The change of GSH-Px of blood
  time frame: Change from Baseline GSH-Px at 12 weeks
  description: Venous blood was sampled to measure GSH-Px
  measure: The change of self-assessment skin and hair condition
  time frame: Change from Baseline skin and hair condition at 12 weeks
  description: A self-assessment questionnaire was collected to evaluate skin and hair condition
  arm group label: Placebo candy
  arm group type: Placebo Comparator
  arm group label: melon and oil olive pressed candy
  arm group type: Experimental
  intervention type: Dietary Supplement
  intervention name: Placebo candy
  description: consume 2 tablets per day
  arm group label: Placebo candy
  intervention type: Dietary Supplement
  intervention name: melon and oil olive pressed candy
  description: consume 2 tablets per day
  arm group label: melon and oil olive pressed candy
  other name: Melon, oil olive and pomegranate blend pressed candy
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chia-Hua Liang, Prof.
  role: Principal Investigator
  affiliation: Chia Nan University of Pharmacy ＆ Science
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Skin Diseases