<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/NCT03811977</url>
  </required_header>
  <id_info>
    <org_study_id>VIST F4F Lutein-MED 01-2018</org_study_id>
    <nct_id>NCT03811977</nct_id>
  </id_info>
  <brief_title>The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters</brief_title>
  <acronym>VIST Lutein</acronym>
  <official_title>The Effect of 12-Week Dietary Intake of Lutein on Minimal Erythema Dose and Other Skin Parameters: Randomised Double-Blind Placebo Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VIST - Faculty of Applied Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Regional Development Fund</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Education, Science and Sport, Republic of Slovenia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dermatologija Bartenjev Rogl</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Slovenian Research Agency</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Valens Int. d.o.o., Slovenija</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>VIST - Faculty of Applied Sciences</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>
      The double-center, randomized, placebo-controlled, one-period effectiveness study will&#xD;
      include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III).&#xD;
      Subjects will be divided in two groups, 15 in each. One group (test group) will receive&#xD;
      investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo&#xD;
      group) placebo syrup. Participants will test continuous administration of placebo or&#xD;
      investigational product for 12 weeks in order to demonstrate and assess multiple-dose&#xD;
      effects. The primary objective is to assess the photoprotective potential of the&#xD;
      investigational product in relation to placebo product. The secondary objectives are to&#xD;
      assess effects of investigational product on dermis density and skin viscoelasticity after 12&#xD;
      weeks of dietary supplementation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 2, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose</measure>
    <time_frame>12 weeks</time_frame>
    <description>The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. It will be assessed through measurements of minimal erythema dose with MED Tester using UVB irradiation. Significant change of minimal erythema dose from baseline in test group, in comparison to placebo group, after 12 weeks of dietary supplementation with study product is expected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement</measure>
    <time_frame>12 weeks</time_frame>
    <description>Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity</measure>
    <time_frame>12 weeks</time_frame>
    <description>For assessments of skin elasticity viscoelasticity measurements will be performed. Significant change of skin easticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Minimal Erythema Dose</condition>
  <condition>Skin Viscoelasticity</condition>
  <condition>Dermis Density</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test group will receive investigational product - lutein syrup (2 mg/mL; daily dose 20 mg). Participants in this group will test continuous administration of investigational product for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg). Continuous administration of placebo product for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lutein syrup</intervention_name>
    <description>12- week dietary supplementation with lutein syrup (20 mg lutein/day)</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo syrup</intervention_name>
    <description>12- week dietary supplementation with placebo syrup (0 mg lutein/day)</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasian female volunteers aged between 25 and 55 years at the time of the signature&#xD;
             of Informed consent form (ICF),&#xD;
&#xD;
          -  Signed Informed consent form (ICF),&#xD;
&#xD;
          -  Fitzpatrick skin phototypes II and III,&#xD;
&#xD;
          -  No skin pigmentation disorders,&#xD;
&#xD;
          -  In good health condition,&#xD;
&#xD;
          -  Willingness to avoid a consumption of any food supplements containing carotenes or&#xD;
             other antioxidants during the study,&#xD;
&#xD;
          -  Willingness to avoid the sun, tanning beds and tanning products on the gluteal area&#xD;
             during the study,&#xD;
&#xD;
          -  Willingness to follow all study procedures and keeping a diary for during the study&#xD;
             (to follow their compliance and palatability),&#xD;
&#xD;
          -  No changes in dietary habits or dietary supplements in last month prior to inclusion.&#xD;
&#xD;
          -  No changes in cosmetic facial and body care routine in last month prior to inclusion&#xD;
             on measurement areas.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or breastfeeding,&#xD;
&#xD;
          -  Known or suspected allergy to any ingredient of the tested products or UV radiation,&#xD;
&#xD;
          -  Changes in dietary habits and dietary supplementation in last month prior to&#xD;
             inclusion,&#xD;
&#xD;
          -  Veganism,&#xD;
&#xD;
          -  Changes in cosmetic facial and body care routine in last month prior to inclusion.&#xD;
&#xD;
          -  Diagnosed and uncontrolled/untreated/unregulated disease,&#xD;
&#xD;
          -  Any clinically significant history of serious metabolic disease, digestive tract&#xD;
             disease, liver disease, kidney disease, haematological disease.&#xD;
&#xD;
          -  Acute skin diseases,&#xD;
&#xD;
          -  Regular consumption of food supplements containing carotenoids or other antioxidants&#xD;
             in last month before inclusion into the study.&#xD;
&#xD;
          -  Invasive rejuvenation treatments (e.g. needle rollers, needle mesotherapy,&#xD;
             deep/medium-deep chemical peels etc.) in last 6 months prior to study entry,&#xD;
&#xD;
          -  Non-invasive rejuvenation treatments (e.g. radiofrequency, electrotherapy, ultrasound&#xD;
             therapy) in last 2 months prior to study entry,&#xD;
&#xD;
          -  Gluteal hyperpigmentation,&#xD;
&#xD;
          -  Mental incapacity that precludes adequate understanding or cooperation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katja Žmitek</last_name>
    <role>Study Director</role>
    <affiliation>Head of Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Higher School of Applied Sciences, Institute of Cosmetics</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>August 30, 2019</last_update_submitted>
  <last_update_submitted_qc>August 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2019</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>Erythema</mesh_term>
  </condition_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/NCT03811977
org study id: VIST F4F Lutein-MED 01-2018
nct id: NCT03811977
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The double-center, randomized, placebo-controlled, one-period effectiveness study will
      include 30 subjects (women, aged between 25 to 55 years, Fitzpatrick phototype II and III).
      Subjects will be divided in two groups, 15 in each. One group (test group) will receive
      investigational product - lutein syrup (4 mg/mL; daily dose 20 mg) and the other (placebo
      group) placebo syrup. Participants will test continuous administration of placebo or
      investigational product for 12 weeks in order to demonstrate and assess multiple-dose
      effects. The primary objective is to assess the photoprotective potential of the
      investigational product in relation to placebo product. The secondary objectives are to
      assess effects of investigational product on dermis density and skin viscoelasticity after 12
      weeks of dietary supplementation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Photoprotective potential of the investigational product in relation to placebo product assessed through measurements of minimal erythema dose
time frame: 12 weeks
description: The primary objective is to assess the photoprotective potential of the investigational product in relation to placebo product. It will be assessed through measurements of minimal erythema dose with MED Tester using UVB irradiation. Significant change of minimal erythema dose from baseline in test group, in comparison to placebo group, after 12 weeks of dietary supplementation with study product is expected.
measure: Influence of investigational product in relation to placebo product on dermis density assessed through dermis intensity measurement
time frame: 12 weeks
description: Significant change of dermis density from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected. Dermis density will be assessed through ultrasonographic dermis intensity measurement.
measure: Influence of the investigational product in relation to placebo product on skin elasticity assessed through measurements of viscoelasticity
time frame: 12 weeks
description: For assessments of skin elasticity viscoelasticity measurements will be performed. Significant change of skin easticity from baseline in test group, in comparison to placebo group after 12 weeks of dietary supplementation with study product is expected.
arm group label: Test group
arm group type: Experimental
description: Test group will receive investigational product - lutein syrup (2 mg/mL; daily dose 20 mg). Participants in this group will test continuous administration of investigational product for 12 weeks.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Placebo group will receive placebo product - placebo syrup (lutein 0 mg/mL; daily dose 0 mg). Continuous administration of placebo product for 12 weeks.
intervention type: Dietary Supplement
intervention name: Lutein syrup
description: 12- week dietary supplementation with lutein syrup (20 mg lutein/day)
arm group label: Test group
intervention type: Dietary Supplement
intervention name: Placebo syrup
description: 12- week dietary supplementation with placebo syrup (0 mg lutein/day)
arm group label: Placebo group
criteria: 
gender: Female
gender based: Yes
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Katja Žmitek
role: Study Director
affiliation: Head of Research Group
facility: 
country: Slovenia
responsible party type: Sponsor
mesh term: Erythema
sharing ipd: No