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/NCT05988554</url>
    </required_header>
    <id_info>
      <org_study_id>23-048-B</org_study_id>
      <nct_id>NCT05988554</nct_id>
    </id_info>
    <brief_title>Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen Products</brief_title>
    <official_title>Efficacy Testing of Hibiscus Sabdariffa Extract and Collagen 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 Hibiscus sabdariffa extract and collagen products on skin condition improvement&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 31, 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 collagen density</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin wrinkles</measure>
      <time_frame>Week 0, week 4, week 8</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>Week 0, week 4, week 8</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 elasticity</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>SoftPlus was utilized to measure skin elasticity. Units: arbitrary units</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of skin moisture</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The change of skin melanin index</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of skin L* value</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of transepidermal water loss (TEWL)</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of skin pores</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The change of skin spots</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units</description>
    </secondary_outcome>
    <other_outcome>
      <measure>The change of self-assessment skin condition</measure>
      <time_frame>Week 0, week 4, week 8</time_frame>
      <description>A self-assessment questionnaire was collected to evaluate skin condition</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Skin Condition</condition>
    <arm_group>
      <arm_group_label>Placebo sachet</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Hibiscus sabdariffa extract and collagen products</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo sachet</intervention_name>
      <description>Consume 1 sachet daily</description>
      <arm_group_label>Placebo sachet</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Hibiscus sabdariffa extract and collagen products</intervention_name>
      <description>Consume 1 sachet daily</description>
      <arm_group_label>Hibiscus sabdariffa extract and collagen products</arm_group_label>
      <other_name>SPRING Collagen Powder</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy adults 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, liver, kidney.&#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 (&gt; 3 hr/week) in&#xD;
               the past 4 weeks.&#xD;
  &#xD;
            -  Constant drug use&#xD;
  &#xD;
            -  Students who are currently taking courses taught by the principal investigator of this&#xD;
               trial.&#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>
    <overall_official>
      <last_name>Chia-Hua Liang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chia Nan University of Pharmacy ＆ Science</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Chia Nan University of Pharmacy ＆ Science</name>
        <address>
          <city>Tainan</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/NCT05988554
  org study id: 23-048-B
  nct id: NCT05988554
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To assess Hibiscus sabdariffa extract and collagen products on skin condition improvement
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: The change of skin collagen density
  time frame: Week 0, week 4, week 8
  description: DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units
  measure: The change of skin wrinkles
  time frame: Week 0, week 4, week 8
  description: VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units
  measure: The change of skin texture
  time frame: Week 0, week 4, week 8
  description: VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units
  measure: The change of skin elasticity
  time frame: Week 0, week 4, week 8
  description: SoftPlus was utilized to measure skin elasticity. Units: arbitrary units
  measure: The change of skin moisture
  time frame: Week 0, week 4, week 8
  description: Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120
  measure: The change of skin melanin index
  time frame: Week 0, week 4, week 8
  description: Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units
  measure: The change of skin L* value
  time frame: Week 0, week 4, week 8
  description: Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100
  measure: The change of transepidermal water loss (TEWL)
  time frame: Week 0, week 4, week 8
  description: Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²
  measure: The change of skin pores
  time frame: Week 0, week 4, week 8
  description: VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units
  measure: The change of skin spots
  time frame: Week 0, week 4, week 8
  description: VISIA Complexion Analysis System was utilized to measure skin spots. Units: arbitrary units
  measure: The change of self-assessment skin condition
  time frame: Week 0, week 4, week 8
  description: A self-assessment questionnaire was collected to evaluate skin condition
  arm group label: Placebo sachet
  arm group type: Placebo Comparator
  arm group label: Hibiscus sabdariffa extract and collagen products
  arm group type: Experimental
  intervention type: Dietary Supplement
  intervention name: Placebo sachet
  description: Consume 1 sachet daily
  arm group label: Placebo sachet
  intervention type: Dietary Supplement
  intervention name: Hibiscus sabdariffa extract and collagen products
  description: Consume 1 sachet daily
  arm group label: Hibiscus sabdariffa extract and collagen products
  other name: SPRING Collagen Powder
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chia-Hua Liang
  role: Principal Investigator
  affiliation: Chia Nan University of Pharmacy ＆ Science
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Skin Diseases