<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/NCT03771807</url>
  </required_header>
  <id_info>
    <org_study_id>18-PHX-0002</org_study_id>
    <nct_id>NCT03771807</nct_id>
  </id_info>
  <brief_title>Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults</brief_title>
  <official_title>A Single-center, Placebo Controlled Study to Investigate the Efficacy of a Nutritional Supplement on Skin Health in Generally Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pharmanex</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dermatology Consulting Services, High Point NC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Pharmanex</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>
      Consumption of dietary supplements has been found to modulate skin health. Individual&#xD;
      ingredients such as collagen peptides, lutein and ceramides have been shown to improve skin&#xD;
      health. Collagen peptides have been shown to clinically improve skin texture, decrease area&#xD;
      of skin ultraviolet damage, increase skin hydration, and improve visible skin results such as&#xD;
      hydration, elasticity, wrinkles and roughness. Lutein has been demonstrated to increase skin&#xD;
      radiance, protect skin from ultraviolet light, and increase skin hydration. Ceramides derived&#xD;
      from wheat have been shown to improve skin texture, increase skin hydration and improve&#xD;
      visible skin attributes such as hydration, elasticity, and wrinkles. This study will have&#xD;
      subjects consuming a nutritional supplement or placebo daily for 90 days to see if there is&#xD;
      an effect on skin health. This study will also have the subjects using a facial cleansing&#xD;
      device, which has been shown to improve skin health, on half of their face to determine if&#xD;
      there is a synergistic effect between dietary supplement and cleansing device. It is&#xD;
      believed, this mixture of collagen peptides, lutein and ceramides has not been studied and&#xD;
      the study sponsor hypothesize that this blend of ingredients will have a positive impact on&#xD;
      skin health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Visit 1 Screening (day -30 to -1): Subjects will be given a copy of the informed consent&#xD;
      document. They will be given ample time to read and formulate questions prior to reviewing&#xD;
      the document with study staff. The consent form will be reviewed with the subject and&#xD;
      questions will be answered. The subject will provide written consent prior to starting any&#xD;
      study related assessments. The study staff will collect the following information during this&#xD;
      visit:&#xD;
&#xD;
        -  Review medical history&#xD;
&#xD;
        -  Review concomitant medications&#xD;
&#xD;
        -  Measure height, weight, BMI, heart rate, blood pressure&#xD;
&#xD;
        -  Review inclusion/exclusion criteria&#xD;
&#xD;
      If the subject meets inclusion/exclusion criteria they will complete the following study&#xD;
      assessments.&#xD;
&#xD;
        -  Skin examination&#xD;
&#xD;
        -  Investigator facial clinical grading&#xD;
&#xD;
        -  Corneometry of both sides of the face and one forearm&#xD;
&#xD;
        -  Colorimeter of both sides of the face and one forearm&#xD;
&#xD;
        -  Elasticity of both sides of the face&#xD;
&#xD;
        -  Carotenoid scan of left hand&#xD;
&#xD;
        -  AGE reader of left forearm&#xD;
&#xD;
        -  Digital photo of face&#xD;
&#xD;
      Visit 2 Baseline (day 0): Subjects will return to the research site for baseline visit&#xD;
      approximately 30 days after their screening visit. Subjects will undergo assessments to&#xD;
      determine that they continue to meet inclusion/exclusion criteria. Subjects who are eligible&#xD;
      will be enrolled into the study and assigned a randomization number and study product. The&#xD;
      following assessments will be completed during this visit:&#xD;
&#xD;
        -  Measure weight, BMI, heart rate, blood pressure&#xD;
&#xD;
        -  Investigator facial clinical grading&#xD;
&#xD;
        -  Subject facial grading&#xD;
&#xD;
        -  Corneometry of both sides of the face and one forearm&#xD;
&#xD;
        -  Colorimeter of both sides of the face and one forearm&#xD;
&#xD;
        -  Elasticity of both sides of the face&#xD;
&#xD;
        -  Carotenoid scan of left hand&#xD;
&#xD;
        -  AGE reader of left forearm&#xD;
&#xD;
        -  10ml Blood draw (Chemistry and CBC)&#xD;
&#xD;
        -  Digital photo of face&#xD;
&#xD;
        -  UV Radiation of buttocks (1MED, 2MED, 3MED)&#xD;
&#xD;
      Visit 3 Baseline + 24hrs (day 1): Subjects will return to the research site approximately&#xD;
      24hrs after their baseline visit. The following assessments will be completed during this&#xD;
      visit:&#xD;
&#xD;
        -  Digital photograph of irradiated buttock site&#xD;
&#xD;
        -  Dermospectrophotometer of irradiated site&#xD;
&#xD;
        -  Dispense 2 months of assigned study product&#xD;
&#xD;
        -  Dispense skin cleansing machine and provide instruction on daily use to the right half&#xD;
           of their face only&#xD;
&#xD;
      Visit 4 (day 30 +5 days): Subjects will return at approximately 30 days after their baseline&#xD;
      visit. Unused study product will be collected and compliance will be calculated. The&#xD;
      following assessments will be completed:&#xD;
&#xD;
        -  Investigator facial clinical grading&#xD;
&#xD;
        -  Subject facial grading&#xD;
&#xD;
        -  Corneometry of both sides of the face and one forearm&#xD;
&#xD;
        -  Colorimeter of both sides of the face and one forearm&#xD;
&#xD;
        -  Elasticity of both sides of the face&#xD;
&#xD;
        -  Carotenoid scan of left hand&#xD;
&#xD;
        -  AGE reader of left forearm&#xD;
&#xD;
        -  Adverse events will be collected by asking if the subject has experienced any changes in&#xD;
           their health&#xD;
&#xD;
        -  Return unused study product and dispense enough assigned study product to make it&#xD;
           through next study visit&#xD;
&#xD;
      Visit 5 (day 60 +5 days): Subjects will return at approximately 60 days after their baseline&#xD;
      visit. Unused study product will be collected and compliance will be calculated. The&#xD;
      following assessments will be completed:&#xD;
&#xD;
        -  Investigator facial clinical grading&#xD;
&#xD;
        -  Subject facial grading&#xD;
&#xD;
        -  Corneometry of both sides of the face and one forearm&#xD;
&#xD;
        -  Colorimeter of both sides of the face and one forearm&#xD;
&#xD;
        -  Elasticity of both sides of the face&#xD;
&#xD;
        -  Carotenoid scan of left hand&#xD;
&#xD;
        -  AGE reader of left forearm&#xD;
&#xD;
        -  Adverse events will be collected by asking if the subject has experienced any changes in&#xD;
           their health&#xD;
&#xD;
        -  Return unused study product and dispense enough assigned study product to make it&#xD;
           through next study visit&#xD;
&#xD;
      Visit 6 (day 90 +5 days): Subjects will return at approximately 90 days after their baseline&#xD;
      visit. Unused study product will be collected and compliance will be calculated. The&#xD;
      following assessments will be completed:&#xD;
&#xD;
        -  Measure weight, BMI, heart rate, blood pressure&#xD;
&#xD;
        -  Investigator facial clinical grading&#xD;
&#xD;
        -  Subject facial grading&#xD;
&#xD;
        -  Corneometry of both sides of the face and one forearm&#xD;
&#xD;
        -  Colorimeter of both sides of the face and one forearm&#xD;
&#xD;
        -  Elasticity of both sides of the face&#xD;
&#xD;
        -  Carotenoid scan of left hand&#xD;
&#xD;
        -  AGE reader of left forearm&#xD;
&#xD;
        -  10ml Blood draw (Chemistry and CBC)&#xD;
&#xD;
        -  Digital photo of face&#xD;
&#xD;
        -  UV Radiation of buttocks (1MED, 2MED, 3MED)&#xD;
&#xD;
        -  Collect skin cleansing machine&#xD;
&#xD;
        -  Adverse events will be collected by asking if the subject has experienced any changes in&#xD;
           their health&#xD;
&#xD;
      Visit 7 (24 hours after visit 6): Subjects will return to the research site approximately&#xD;
      24hrs after visit 6. The following assessments will be completed during this visit:&#xD;
&#xD;
        -  Digital photograph of irradiated buttock site&#xD;
&#xD;
        -  Dermospectrophotometer of irradiated site&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2020</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin Health (lines)</measure>
    <time_frame>baseline, day 30, day 60, and day 90</time_frame>
    <description>Change from baseline in investigator and subject facial grading of lines (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin Health (firmness)</measure>
    <time_frame>baseline, day 30, day 60, and day 90</time_frame>
    <description>Change from baseline in investigator and subject facial grading of firmness (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin Health (radiance)</measure>
    <time_frame>baseline, day 30, day 60, and day 90</time_frame>
    <description>Change from baseline in investigator and subject facial grading of radiance (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin Health (texture)</measure>
    <time_frame>baseline, day 30, day 60, and day 90</time_frame>
    <description>Change from baseline in investigator and subject facial grading of texture (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin Health (overall)</measure>
    <time_frame>baseline, day 30, day 60, and day 90</time_frame>
    <description>Change from baseline in investigator and subject facial grading overall (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cellular protection of the skin as determined by dermospectrophotometer of UV irradiated site</measure>
    <time_frame>baseline, and day 91</time_frame>
    <description>Change from baseline in dermospectrophotometer at day 91 using Student T-test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin elasticity of face determined by cutometer</measure>
    <time_frame>baseline, day 30, day 60, and day 90</time_frame>
    <description>Change from baseline in skin elasticity at days 30, 60, and 90 using Student T-test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ramen skin carotenoids score determined by carotenoid scan of left hand</measure>
    <time_frame>baseline, day 30, day 60, and day 90</time_frame>
    <description>Change from baseline in skin carotenoids at days 30, 60, and 90 using Student T-test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benefits of facial cleansing in concurrence with dietary supplement</measure>
    <time_frame>baseline, day 30, day 60, and day 90</time_frame>
    <description>Determine if facial cleansing improves outcomes over dietary supplement use alone as determined by investigator assessment using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe in lines, firmness, radiance, texture, and overall of both sides of the subjects face</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Skin Health</condition>
  <arm_group>
    <arm_group_label>Placebo &amp; facial cleansing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin and food coloring&#xD;
Subjects will clean the right side of their face with a cosmetic instrument daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Beauty From Within &amp; facial cleansing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study Product contains collagen hydrolysate, ceramide wheat extract oil and lutein&#xD;
Subjects will clean the right side of their face with a cosmetic instrument daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Beauty From Within</intervention_name>
    <description>one scoop of product mixed in 8-16 ounces of water consumed once daily</description>
    <arm_group_label>Beauty From Within &amp; facial cleansing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>one scoop of product mixed in 8-16 ounces of water consumed once daily</description>
    <arm_group_label>Placebo &amp; facial cleansing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Facial cleansing</intervention_name>
    <description>All subjects will use a cosmetic instrument to clean on one half of their face daily</description>
    <arm_group_label>Beauty From Within &amp; facial cleansing</arm_group_label>
    <arm_group_label>Placebo &amp; facial cleansing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females 40 - 60 years of age&#xD;
&#xD;
          2. Individuals must present with stable moderate signs of aging that does not change&#xD;
             between the screening visit and the baseline visit 4 weeks later&#xD;
&#xD;
          3. Subject is willing and able to participate in all aspects of the study&#xD;
&#xD;
          4. Individuals must sign informed consent, photo release consent and confidentiality&#xD;
             agreement&#xD;
&#xD;
          5. Subject has a BMI &gt; 19 and &lt; 32&#xD;
&#xD;
          6. Subject must be on a stable dose of chronic use medications for at least 3 months&#xD;
             prior to study participation&#xD;
&#xD;
          7. Subject who, in the opinion of the investigator, are free of any medical condition(s)&#xD;
             that may interfere with study participation or affect study measures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals that are being treated for cancer or have a history of facial skin cancer&#xD;
&#xD;
          2. Individuals with sunburn, moderate to pronounced suntan, uneven skin tones, tattoos,&#xD;
             scares or other disfiguration, dilated vessels or other conditions on the test area&#xD;
             that might influence the test results&#xD;
&#xD;
          3. Any disease or condition of the skin that the investigator deems inappropriate for&#xD;
             participation, including rosacea, eczema, psoriasis, and atopic dermatitis&#xD;
&#xD;
          4. Individuals currently taking medications which in the opinion of the investigator may&#xD;
             interfere with the study. This would include but not be limited to all oral&#xD;
             corticosteroids, use of anti-inflammatory drugs more than 14 consecutive days,&#xD;
             immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye&#xD;
             drops are permitted), hormone replacement therapy and insulin, antibiotics or other&#xD;
             topical drugs at the test sites&#xD;
&#xD;
          5. Individuals with uncontrolled metabolic diseases such as diabetes (type I and II),&#xD;
             hypertension, hyperthyroidism or hypothyroidism, severe chronic asthma, immunological&#xD;
             disorders such as HIV, AIDS and systemic lupus erythematosus or mastectomy for cancer&#xD;
             involving removal of lymph nodes&#xD;
&#xD;
          6. Subject is taking skin, nail, and hair health promoting supplement orally (including&#xD;
             products containing collagen and carotenoids)&#xD;
&#xD;
          7. Women known to be pregnant, nursing, or planning to become pregnant&#xD;
&#xD;
          8. Individuals participating in other facial clinical trials&#xD;
&#xD;
          9. Individuals who have routinely used alpha-hydroxy-acid (AHA) or a beta-hydroxy-acid&#xD;
             (BHA) containing product within two weeks of baseline visit or Retin-A®, Retin-A&#xD;
             Micro®, Renova®, Differin®, Avita®, Tazorac®, or Soriatane® within one month of&#xD;
             baseline visit or have taken Accutane® within one year of baseline visit. Individuals&#xD;
             who have used Retinol in the last six months prior to baseline visit&#xD;
&#xD;
         10. Individuals with inflammatory acne lesions (i.e., papules, pustules, cysts, nodules)&#xD;
             at the test site&#xD;
&#xD;
         11. Individuals who have had chemical peels or dermabrasion within the last six months&#xD;
             prior to baseline visit&#xD;
&#xD;
         12. Individuals who have sun tanned (sun or tanning beds) in the nude within the past 1&#xD;
             year prior to baseline visit&#xD;
&#xD;
         13. Excessive alcohol use (&gt;2 drinks per day)&#xD;
&#xD;
         14. Subject is a current smoker or quit less than 3 years from screening visit&#xD;
&#xD;
         15. History of substance abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zoe D Draelos, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dermatology Consulting Services, High Point NC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology Consulting Services</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bizot, V., E. Cestone, A. Michelotti and V. Nobile. Improving skin hydration and age-related symptoms by oral administration of wheat glucosylceramides and digalactosyl diglycerides: a human clinical study. Cosmetics 4(37): 2017</citation>
  </reference>
  <reference>
    <citation>Juturu V, Bowman JP, Deshpande J. Overall skin tone and skin-lightening-improving effects with oral supplementation of lutein and zeaxanthin isomers: a double-blind, placebo-controlled clinical trial. Clin Cosmet Investig Dermatol. 2016 Oct 7;9:325-332. doi: 10.2147/CCID.S115519. eCollection 2016.</citation>
    <PMID>27785083</PMID>
  </reference>
  <reference>
    <citation>Morganti P, Fabrizi G, Bruno C. Protective effects of oral antioxidants on skin and eye function. Skinmed. 2004 Nov-Dec;3(6):310-6. doi: 10.1111/j.1540-9740.2004.02420.x.</citation>
    <PMID>15538079</PMID>
  </reference>
  <reference>
    <citation>Palombo P, Fabrizi G, Ruocco V, Ruocco E, Fluhr J, Roberts R, Morganti P. Beneficial long-term effects of combined oral/topical antioxidant treatment with the carotenoids lutein and zeaxanthin on human skin: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2007;20(4):199-210. doi: 10.1159/000101807. Epub 2007 Apr 19.</citation>
    <PMID>17446716</PMID>
  </reference>
  <reference>
    <citation>Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24.</citation>
    <PMID>24401291</PMID>
  </reference>
  <reference>
    <citation>Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14.</citation>
    <PMID>23949208</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</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/NCT03771807
org study id: 18-PHX-0002
nct id: NCT03771807
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Consumption of dietary supplements has been found to modulate skin health. Individual
      ingredients such as collagen peptides, lutein and ceramides have been shown to improve skin
      health. Collagen peptides have been shown to clinically improve skin texture, decrease area
      of skin ultraviolet damage, increase skin hydration, and improve visible skin results such as
      hydration, elasticity, wrinkles and roughness. Lutein has been demonstrated to increase skin
      radiance, protect skin from ultraviolet light, and increase skin hydration. Ceramides derived
      from wheat have been shown to improve skin texture, increase skin hydration and improve
      visible skin attributes such as hydration, elasticity, and wrinkles. This study will have
      subjects consuming a nutritional supplement or placebo daily for 90 days to see if there is
      an effect on skin health. This study will also have the subjects using a facial cleansing
      device, which has been shown to improve skin health, on half of their face to determine if
      there is a synergistic effect between dietary supplement and cleansing device. It is
      believed, this mixture of collagen peptides, lutein and ceramides has not been studied and
      the study sponsor hypothesize that this blend of ingredients will have a positive impact on
      skin health.
Visit 1 Screening (day -30 to -1): Subjects will be given a copy of the informed consent
      document. They will be given ample time to read and formulate questions prior to reviewing
      the document with study staff. The consent form will be reviewed with the subject and
      questions will be answered. The subject will provide written consent prior to starting any
      study related assessments. The study staff will collect the following information during this
      visit:

        -  Review medical history

        -  Review concomitant medications

        -  Measure height, weight, BMI, heart rate, blood pressure

        -  Review inclusion/exclusion criteria

      If the subject meets inclusion/exclusion criteria they will complete the following study
      assessments.

        -  Skin examination

        -  Investigator facial clinical grading

        -  Corneometry of both sides of the face and one forearm

        -  Colorimeter of both sides of the face and one forearm

        -  Elasticity of both sides of the face

        -  Carotenoid scan of left hand

        -  AGE reader of left forearm

        -  Digital photo of face

      Visit 2 Baseline (day 0): Subjects will return to the research site for baseline visit
      approximately 30 days after their screening visit. Subjects will undergo assessments to
      determine that they continue to meet inclusion/exclusion criteria. Subjects who are eligible
      will be enrolled into the study and assigned a randomization number and study product. The
      following assessments will be completed during this visit:

        -  Measure weight, BMI, heart rate, blood pressure

        -  Investigator facial clinical grading

        -  Subject facial grading

        -  Corneometry of both sides of the face and one forearm

        -  Colorimeter of both sides of the face and one forearm

        -  Elasticity of both sides of the face

        -  Carotenoid scan of left hand

        -  AGE reader of left forearm

        -  10ml Blood draw (Chemistry and CBC)

        -  Digital photo of face

        -  UV Radiation of buttocks (1MED, 2MED, 3MED)

      Visit 3 Baseline + 24hrs (day 1): Subjects will return to the research site approximately
      24hrs after their baseline visit. The following assessments will be completed during this
      visit:

        -  Digital photograph of irradiated buttock site

        -  Dermospectrophotometer of irradiated site

        -  Dispense 2 months of assigned study product

        -  Dispense skin cleansing machine and provide instruction on daily use to the right half
           of their face only

      Visit 4 (day 30 +5 days): Subjects will return at approximately 30 days after their baseline
      visit. Unused study product will be collected and compliance will be calculated. The
      following assessments will be completed:

        -  Investigator facial clinical grading

        -  Subject facial grading

        -  Corneometry of both sides of the face and one forearm

        -  Colorimeter of both sides of the face and one forearm

        -  Elasticity of both sides of the face

        -  Carotenoid scan of left hand

        -  AGE reader of left forearm

        -  Adverse events will be collected by asking if the subject has experienced any changes in
           their health

        -  Return unused study product and dispense enough assigned study product to make it
           through next study visit

      Visit 5 (day 60 +5 days): Subjects will return at approximately 60 days after their baseline
      visit. Unused study product will be collected and compliance will be calculated. The
      following assessments will be completed:

        -  Investigator facial clinical grading

        -  Subject facial grading

        -  Corneometry of both sides of the face and one forearm

        -  Colorimeter of both sides of the face and one forearm

        -  Elasticity of both sides of the face

        -  Carotenoid scan of left hand

        -  AGE reader of left forearm

        -  Adverse events will be collected by asking if the subject has experienced any changes in
           their health

        -  Return unused study product and dispense enough assigned study product to make it
           through next study visit

      Visit 6 (day 90 +5 days): Subjects will return at approximately 90 days after their baseline
      visit. Unused study product will be collected and compliance will be calculated. The
      following assessments will be completed:

        -  Measure weight, BMI, heart rate, blood pressure

        -  Investigator facial clinical grading

        -  Subject facial grading

        -  Corneometry of both sides of the face and one forearm

        -  Colorimeter of both sides of the face and one forearm

        -  Elasticity of both sides of the face

        -  Carotenoid scan of left hand

        -  AGE reader of left forearm

        -  10ml Blood draw (Chemistry and CBC)

        -  Digital photo of face

        -  UV Radiation of buttocks (1MED, 2MED, 3MED)

        -  Collect skin cleansing machine

        -  Adverse events will be collected by asking if the subject has experienced any changes in
           their health

      Visit 7 (24 hours after visit 6): Subjects will return to the research site approximately
      24hrs after visit 6. The following assessments will be completed during this visit:

        -  Digital photograph of irradiated buttock site

        -  Dermospectrophotometer of irradiated site
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Skin Health (lines)
time frame: baseline, day 30, day 60, and day 90
description: Change from baseline in investigator and subject facial grading of lines (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
measure: Skin Health (firmness)
time frame: baseline, day 30, day 60, and day 90
description: Change from baseline in investigator and subject facial grading of firmness (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
measure: Skin Health (radiance)
time frame: baseline, day 30, day 60, and day 90
description: Change from baseline in investigator and subject facial grading of radiance (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
measure: Skin Health (texture)
time frame: baseline, day 30, day 60, and day 90
description: Change from baseline in investigator and subject facial grading of texture (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
measure: Skin Health (overall)
time frame: baseline, day 30, day 60, and day 90
description: Change from baseline in investigator and subject facial grading overall (using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe) at days 30, 60, and 90 using Mann Whitney two tailed assessment for nonparametric data
measure: Cellular protection of the skin as determined by dermospectrophotometer of UV irradiated site
time frame: baseline, and day 91
description: Change from baseline in dermospectrophotometer at day 91 using Student T-test
measure: Skin elasticity of face determined by cutometer
time frame: baseline, day 30, day 60, and day 90
description: Change from baseline in skin elasticity at days 30, 60, and 90 using Student T-test
measure: Ramen skin carotenoids score determined by carotenoid scan of left hand
time frame: baseline, day 30, day 60, and day 90
description: Change from baseline in skin carotenoids at days 30, 60, and 90 using Student T-test
measure: Benefits of facial cleansing in concurrence with dietary supplement
time frame: baseline, day 30, day 60, and day 90
description: Determine if facial cleansing improves outcomes over dietary supplement use alone as determined by investigator assessment using a scale 0=none, 1=minimal, 2=mild, 3=moderate, 4=severe in lines, firmness, radiance, texture, and overall of both sides of the subjects face
arm group label: Placebo & facial cleansing
arm group type: Placebo Comparator
description: Maltodextrin and food coloring
Subjects will clean the right side of their face with a cosmetic instrument daily
arm group label: Beauty From Within & facial cleansing
arm group type: Active Comparator
description: Study Product contains collagen hydrolysate, ceramide wheat extract oil and lutein
Subjects will clean the right side of their face with a cosmetic instrument daily
intervention type: Dietary Supplement
intervention name: Beauty From Within
description: one scoop of product mixed in 8-16 ounces of water consumed once daily
arm group label: Beauty From Within & facial cleansing
intervention type: Other
intervention name: Placebo
description: one scoop of product mixed in 8-16 ounces of water consumed once daily
arm group label: Placebo & facial cleansing
intervention type: Other
intervention name: Facial cleansing
description: All subjects will use a cosmetic instrument to clean on one half of their face daily
arm group label: Beauty From Within & facial cleansing
arm group label: Placebo & facial cleansing
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Zoe D Draelos, MD
role: Principal Investigator
affiliation: Dermatology Consulting Services, High Point NC
facility: 
country: United States
citation: Bizot, V., E. Cestone, A. Michelotti and V. Nobile. Improving skin hydration and age-related symptoms by oral administration of wheat glucosylceramides and digalactosyl diglycerides: a human clinical study. Cosmetics 4(37): 2017
citation: Juturu V, Bowman JP, Deshpande J. Overall skin tone and skin-lightening-improving effects with oral supplementation of lutein and zeaxanthin isomers: a double-blind, placebo-controlled clinical trial. Clin Cosmet Investig Dermatol. 2016 Oct 7;9:325-332. doi: 10.2147/CCID.S115519. eCollection 2016.
PMID: 27785083
citation: Morganti P, Fabrizi G, Bruno C. Protective effects of oral antioxidants on skin and eye function. Skinmed. 2004 Nov-Dec;3(6):310-6. doi: 10.1111/j.1540-9740.2004.02420.x.
PMID: 15538079
citation: Palombo P, Fabrizi G, Ruocco V, Ruocco E, Fluhr J, Roberts R, Morganti P. Beneficial long-term effects of combined oral/topical antioxidant treatment with the carotenoids lutein and zeaxanthin on human skin: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2007;20(4):199-210. doi: 10.1159/000101807. Epub 2007 Apr 19.
PMID: 17446716
citation: Proksch E, Schunck M, Zague V, Segger D, Degwert J, Oesser S. Oral intake of specific bioactive collagen peptides reduces skin wrinkles and increases dermal matrix synthesis. Skin Pharmacol Physiol. 2014;27(3):113-9. doi: 10.1159/000355523. Epub 2013 Dec 24.
PMID: 24401291
citation: Proksch E, Segger D, Degwert J, Schunck M, Zague V, Oesser S. Oral supplementation of specific collagen peptides has beneficial effects on human skin physiology: a double-blind, placebo-controlled study. Skin Pharmacol Physiol. 2014;27(1):47-55. doi: 10.1159/000351376. Epub 2013 Aug 14.
PMID: 23949208
responsible party type: Sponsor
sharing ipd: No