<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/NCT03769779</url>
  </required_header>
  <id_info>
    <org_study_id>4251KM0918</org_study_id>
    <nct_id>NCT03769779</nct_id>
  </id_info>
  <brief_title>Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health</brief_title>
  <official_title>A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kemin Foods LC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kemin Foods LC</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>
      Therefore, the present study is designed to contribute to the body of literature by&#xD;
      investigating the effect of 12-weeks of lutein supplementation on multiple parameters of skin&#xD;
      health and appearance in healthy women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blind, placebo-controlled, parallel twelve-week study of the&#xD;
      performance of an oral test product to evaluate the effects of twelve weeks of lutein&#xD;
      supplementation on skin health and appearance in healthy women. A seven-day washout period&#xD;
      will precede the evaluation period. The subjects in each cohort will use consume one softgel&#xD;
      of their assigned test product (treatment or placebo) daily in the morning with breakfast for&#xD;
      12 weeks. Changes in skin condition and appearance as well as blood chemistry will be&#xD;
      assessed using results from expert visual grading, instrumental assessments, skin and blood&#xD;
      assays and subjective questionnaire responses. Subjects will be recruited during the winter&#xD;
      season to account for seasonal variations of skin parameters.&#xD;
&#xD;
      Evaluation points will occur pre-application (Baseline; Week 0) and after 42 and 84 days of&#xD;
      use (D42, D84; Week 6, Week 12). Data will be collected on the following outcomes:&#xD;
&#xD;
      1. Skin Hydration 2. Skin texture/smoothness 2. Reduction of facial fine lines and wrinkles&#xD;
      3. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert&#xD;
      clinical grading and subjective questionnaire responses.&#xD;
&#xD;
      6. Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2019</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 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>
    <intervention_model_description>Randomized, Double-Blind, Placebo-Controlled, Parallel Study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Envelopes that contain information regarding the coding of treatment and placebo will be provided to Sponsor, Site, and PI and kept in a secure location. Envelopes will be readily available for the investigator or site to open in the event that it becomes necessary to know which product a participant is taking for the sake of the participant health care. The sponsor must be notified of any unblinding by the site within 24 hours.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Skin Hydration</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Corneometer Value</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective Skin Hydration</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Subjective Questionnaire Visual Analog Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Skin Texture</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Expert clinical grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Skin Texture</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Subjective Questionnaire Visual Analog Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Facial Lines and Wrinkles</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Expert clinical grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Facial Lines and Wrinkles</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Subjective Questionnaire Visual Analog Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Sagging skin, dry skin, skin tone, and overall appearance</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Expert clinical grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Sagging skin, dry skin, skin tone, and overall appearance</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Subjective Questionnaire Visual Analog Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Skin elasticity</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Expert clinical grading</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Skin elasticity</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Subjective Questionnaire Visual Analog Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Collagen Ultrasound</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Collagen SIAsScope</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>SIAsScope assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Lipids</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>HPLC of tape strips</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Carotenoids</measure>
    <time_frame>ANOVA including weeks 6 and 12</time_frame>
    <description>Total carotenoid concentration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Aging</condition>
  <condition>Wrinkle</condition>
  <condition>Skin Elasticity</condition>
  <condition>Healthy</condition>
  <condition>Hydration</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lutein (FloraGLO™) in safflower oil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>safflower oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>FloraGLO Lutein</intervention_name>
    <description>Lutein (FloraGLO™) in safflower oil</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Safflower Oil</intervention_name>
    <description>Safflower Oil</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Females in good health, and between the ages of 30 and 65 years old&#xD;
&#xD;
          2. Fitzpatrick Skin Type I-V&#xD;
&#xD;
          3. Mild to moderate loss of skin elasticity, wrinkles (global) and rough skin texture&#xD;
&#xD;
          4. Able to read, understand and sign an informed consent form&#xD;
&#xD;
          5. Willing and able to follow all study directions, attend study visits as scheduled and&#xD;
             willing to accept the restrictions of the study&#xD;
&#xD;
          6. Willing and able to maintain regular diet, exercise, hydration, and sleep patterns&#xD;
             throughout the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participating in any other clinical study&#xD;
&#xD;
          2. Acute or chronic disease or medical condition&#xD;
&#xD;
          3. Unreliable or unlikely to be available for the duration of the study&#xD;
&#xD;
          4. Routine use of tanning bed(s)&#xD;
&#xD;
          5. History of abnormal response to sunshine&#xD;
&#xD;
          6. Current usage of medications with contraindication of enhancing sun exposure, or&#xD;
             medications for skin conditions.&#xD;
&#xD;
          7. History of allergic reactions, skin sensitization and/or known allergies to cosmetic&#xD;
             ingredients, toiletries, sunscreens, etc.&#xD;
&#xD;
          8. Immunocompromised subjects&#xD;
&#xD;
          9. Subject has a history of unconventional sleep patterns&#xD;
&#xD;
         10. Started Hormone Replacement Therapy within the last three months&#xD;
&#xD;
         11. Using oral contraception for less than three months&#xD;
&#xD;
         12. Known to be pregnant, lactating or planning to become pregnant within six months&#xD;
&#xD;
         13. Unable to communicate or cooperate with the Principal Investigator due to language&#xD;
             problems, poor mental development, or impaired cerebral function&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>International Research Services, Inc.</name>
      <address>
        <city>Port Chester</city>
        <state>New York</state>
        <zip>10573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03769779
org study id: 4251KM0918
nct id: NCT03769779
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Therefore, the present study is designed to contribute to the body of literature by
      investigating the effect of 12-weeks of lutein supplementation on multiple parameters of skin
      health and appearance in healthy women.
This is a randomized, double-blind, placebo-controlled, parallel twelve-week study of the
      performance of an oral test product to evaluate the effects of twelve weeks of lutein
      supplementation on skin health and appearance in healthy women. A seven-day washout period
      will precede the evaluation period. The subjects in each cohort will use consume one softgel
      of their assigned test product (treatment or placebo) daily in the morning with breakfast for
      12 weeks. Changes in skin condition and appearance as well as blood chemistry will be
      assessed using results from expert visual grading, instrumental assessments, skin and blood
      assays and subjective questionnaire responses. Subjects will be recruited during the winter
      season to account for seasonal variations of skin parameters.

      Evaluation points will occur pre-application (Baseline; Week 0) and after 42 and 84 days of
      use (D42, D84; Week 6, Week 12). Data will be collected on the following outcomes:

      1. Skin Hydration 2. Skin texture/smoothness 2. Reduction of facial fine lines and wrinkles
      3. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert
      clinical grading and subjective questionnaire responses.

      6. Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, Double-Blind, Placebo-Controlled, Parallel Study
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Envelopes that contain information regarding the coding of treatment and placebo will be provided to Sponsor, Site, and PI and kept in a secure location. Envelopes will be readily available for the investigator or site to open in the event that it becomes necessary to know which product a participant is taking for the sake of the participant health care. The sponsor must be notified of any unblinding by the site within 24 hours.
measure: Objective Skin Hydration
time frame: ANOVA including weeks 6 and 12
description: Corneometer Value
measure: Subjective Skin Hydration
time frame: ANOVA including weeks 6 and 12
description: Subjective Questionnaire Visual Analog Scale
measure: Objective Skin Texture
time frame: ANOVA including weeks 6 and 12
description: Expert clinical grading
measure: Subjective Skin Texture
time frame: ANOVA including weeks 6 and 12
description: Subjective Questionnaire Visual Analog Scale
measure: Objective Facial Lines and Wrinkles
time frame: ANOVA including weeks 6 and 12
description: Expert clinical grading
measure: Subjective Facial Lines and Wrinkles
time frame: ANOVA including weeks 6 and 12
description: Subjective Questionnaire Visual Analog Scale
measure: Objective Sagging skin, dry skin, skin tone, and overall appearance
time frame: ANOVA including weeks 6 and 12
description: Expert clinical grading
measure: Subjective Sagging skin, dry skin, skin tone, and overall appearance
time frame: ANOVA including weeks 6 and 12
description: Subjective Questionnaire Visual Analog Scale
measure: Objective Skin elasticity
time frame: ANOVA including weeks 6 and 12
description: Expert clinical grading
measure: Subjective Skin elasticity
time frame: ANOVA including weeks 6 and 12
description: Subjective Questionnaire Visual Analog Scale
measure: Skin Collagen Ultrasound
time frame: ANOVA including weeks 6 and 12
description: Ultrasound
measure: Skin Collagen SIAsScope
time frame: ANOVA including weeks 6 and 12
description: SIAsScope assessments
measure: Skin Lipids
time frame: ANOVA including weeks 6 and 12
description: HPLC of tape strips
measure: Skin Carotenoids
time frame: ANOVA including weeks 6 and 12
description: Total carotenoid concentration
arm group label: Treatment
arm group type: Experimental
description: Lutein (FloraGLO™) in safflower oil
arm group label: Placebo
arm group type: Placebo Comparator
description: safflower oil
intervention type: Dietary Supplement
intervention name: FloraGLO Lutein
description: Lutein (FloraGLO™) in safflower oil
arm group label: Treatment
intervention type: Dietary Supplement
intervention name: Safflower Oil
description: Safflower Oil
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No