<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/NCT03819179</url>
  </required_header>
  <id_info>
    <org_study_id>1161875</org_study_id>
    <nct_id>NCT03819179</nct_id>
  </id_info>
  <brief_title>The Influence of Personal Care Products on the Skin Microbiome</brief_title>
  <official_title>The Influence of Personal Care Products on the Skin Microbiome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To evaluate whether personal care products shift the skin microbiome bacteria and diversity&#xD;
      after a week of daily use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have shown that microbiome is important in skin conditions such as eczema, rosacea,&#xD;
      acne, and many other skin conditions. Personal care products are widely used on a daily basis&#xD;
      but it is not know how these personal care products shift the skin's microbiome. The&#xD;
      diversity of the skin microbiome is important in the maintenance of skin equilibrium as a&#xD;
      loss of diversity predisposes to development of skin disease.&#xD;
&#xD;
      The aim of this study is to evaluate multiple over the counter products that are used on the&#xD;
      face daily to assess how they alter skin microbiome and diversity of microflora on skin after&#xD;
      a week of daily treatment.&#xD;
&#xD;
      A second aim of the study is to assess how baseline diversity of microbiome are different&#xD;
      based on self-graded skin types.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Actual">February 6, 2018</completion_date>
  <primary_completion_date type="Actual">February 6, 2018</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in skin microflora</measure>
    <time_frame>Baseline, 7 days</time_frame>
    <description>Cotton swabs will be used to collect sample skin microbiome bacteria from the cheeks and forehead at baseline and 1 week after daily use of the intervention product. These samples will be analysed and the relative components of the microbiome will be a primary outcome.The collected measurement data will be based on a number of operational taxonomic unit (OTU).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in skin microbiome diversity</measure>
    <time_frame>Baseline, 7 days</time_frame>
    <description>Cotton swabs will be used to collect sample skin microbiome bacteria from the cheeks and forehead at baseline and 1 week after daily use of the intervention product. These samples will be analysed and change in diversity of the microbiome will constitute a primary outcome. The collected measurement data will be based on a number of operational taxonomic unit (OTU).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-graded skin type</measure>
    <time_frame>Baseline</time_frame>
    <description>Types are based on the Fitzpatrick Skin Type Questionnaire, which assesses various items on Genetic Disposition, Reaction to Sun Exposure, and Tanning Habits on a score from 0-4. Skin type I corresponds to a total score of 0-7. Skin type II corresponds to a total score of 8-16. Skin type III corresponds to a total score of 17-25. Skin type IV corresponds to a total score of 25-30. Skin type V-VI correspond to a total score of over 30.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Microbiome</condition>
  <arm_group>
    <arm_group_label>Serum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burt's Bees Serum</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serum with Biulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burt's Bees Serum with Biulin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serum with Berenew Complex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burt's Bees Serum with Berenew Complex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serum with Ecoskin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burt's Bees Serum with Ecoskin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serum with Bonicell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Burt's Bees Serum with Bonicell</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Burt's Bees Serum</intervention_name>
    <description>This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol.</description>
    <arm_group_label>Serum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Burt's Bees Serum with Biulin</intervention_name>
    <description>This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, PreBIULIN FOS (GOVA).</description>
    <arm_group_label>Serum with Biulin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Burt's Bees Serum with Bonicell</intervention_name>
    <description>This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, Bonicel (Ganaden).</description>
    <arm_group_label>Serum with Bonicell</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Burt's Bees Serum with Berenew Complex</intervention_name>
    <description>This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, BeRenew CLR Complex (CLR).</description>
    <arm_group_label>Serum with Berenew Complex</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Burt's Bees Serum with Ecoskin</intervention_name>
    <description>This is a commercially available over-the-counter product. Ingredients: Caprylic/Capric Triglyceride, Dimer Dilinoleyl Dimer Dilionoleatem, Silica, Citronellyl Methylcrotonate, Tocopheryl Acetate, Xymenynic Acid, Alpha-glucan Oligosaccharide, Fragrance, Slareolide, Polymnia sonshifolia root juice, Helianthus annuus (sunflower) seed oil, Maltodextrin, Tocopherol, Beta-sitosterol, Lactobacillus, Squalene.</description>
    <arm_group_label>Serum with Ecoskin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females, aged 20-45 (limiting to females so that there is not heterogeneity with the&#xD;
             influence of hormones. Also, females are a much larger user base of personal care&#xD;
             products)&#xD;
&#xD;
          -  Individuals in good general health&#xD;
&#xD;
          -  Individuals free of any dermatological or systemic disorder, which would interfere&#xD;
             with the results, at the discretion of the investigator&#xD;
&#xD;
          -  Individuals who have participated in any other clinical studies using the same test&#xD;
             sites (face) in the past 14 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who have been on any topical antibiotic for the past one month or oral&#xD;
             antibiotic therapy for the past 2 months or are currently on any antibiotic therapy&#xD;
&#xD;
          -  Individuals who have history of acute or chronic disease that would likely interfere&#xD;
             with or increase the risk on study participation at the discretion of the investigator&#xD;
&#xD;
          -  Individuals with active (flaring) disease or chronic skin allergies (atopic&#xD;
             dermatitis/eczema) or those who have recently undergone treatment for skin cancer&#xD;
             (within the last 12 months) in the area of testing on the nose and the cheeks&#xD;
&#xD;
          -  Female volunteers who are pregnant or are actively nursing&#xD;
&#xD;
          -  Female volunteers who have started a new hormonal birth control agent or switched to a&#xD;
             hormonal birth control agent within the past 60 days&#xD;
&#xD;
          -  Individuals who have had any medical or cosmetic procedure, such as laser resurfacing,&#xD;
             or plastic surgery to the test site (face) within the last 6 months. This includes&#xD;
             botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure&#xD;
&#xD;
          -  Individuals who are currently using or during the past 30 days have used a retinoid&#xD;
             such as Retin A, or other Rx/over the counter (OTC) Retinyl A or currently using or&#xD;
             during the past 14 days have used hydroquinone (skin lightening)&#xD;
&#xD;
          -  Individuals with a known history of hypersensitivity to any ingredients to the&#xD;
             cosmetic agent that is being assessed&#xD;
&#xD;
          -  Individuals with self-reported oily skin that may predispose them to acne form&#xD;
             breakouts (at the discretion of the investigator)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Females, aged 20-45</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC Davis Department of Dermatology, Clinical Trials Unit</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</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/NCT03819179
org study id: 1161875
nct id: NCT03819179
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate whether personal care products shift the skin microbiome bacteria and diversity
      after a week of daily use.
Studies have shown that microbiome is important in skin conditions such as eczema, rosacea,
      acne, and many other skin conditions. Personal care products are widely used on a daily basis
      but it is not know how these personal care products shift the skin's microbiome. The
      diversity of the skin microbiome is important in the maintenance of skin equilibrium as a
      loss of diversity predisposes to development of skin disease.

      The aim of this study is to evaluate multiple over the counter products that are used on the
      face daily to assess how they alter skin microbiome and diversity of microflora on skin after
      a week of daily treatment.

      A second aim of the study is to assess how baseline diversity of microbiome are different
      based on self-graded skin types.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change in skin microflora
time frame: Baseline, 7 days
description: Cotton swabs will be used to collect sample skin microbiome bacteria from the cheeks and forehead at baseline and 1 week after daily use of the intervention product. These samples will be analysed and the relative components of the microbiome will be a primary outcome.The collected measurement data will be based on a number of operational taxonomic unit (OTU).
measure: Change in skin microbiome diversity
time frame: Baseline, 7 days
description: Cotton swabs will be used to collect sample skin microbiome bacteria from the cheeks and forehead at baseline and 1 week after daily use of the intervention product. These samples will be analysed and change in diversity of the microbiome will constitute a primary outcome. The collected measurement data will be based on a number of operational taxonomic unit (OTU).
measure: Self-graded skin type
time frame: Baseline
description: Types are based on the Fitzpatrick Skin Type Questionnaire, which assesses various items on Genetic Disposition, Reaction to Sun Exposure, and Tanning Habits on a score from 0-4. Skin type I corresponds to a total score of 0-7. Skin type II corresponds to a total score of 8-16. Skin type III corresponds to a total score of 17-25. Skin type IV corresponds to a total score of 25-30. Skin type V-VI correspond to a total score of over 30.
arm group label: Serum
arm group type: Experimental
description: Burt's Bees Serum
arm group label: Serum with Biulin
arm group type: Experimental
description: Burt's Bees Serum with Biulin
arm group label: Serum with Berenew Complex
arm group type: Experimental
description: Burt's Bees Serum with Berenew Complex
arm group label: Serum with Ecoskin
arm group type: Experimental
description: Burt's Bees Serum with Ecoskin
arm group label: Serum with Bonicell
arm group type: Experimental
description: Burt's Bees Serum with Bonicell
intervention type: Other
intervention name: Burt's Bees Serum
description: This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol.
arm group label: Serum
intervention type: Other
intervention name: Burt's Bees Serum with Biulin
description: This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, PreBIULIN FOS (GOVA).
arm group label: Serum with Biulin
intervention type: Other
intervention name: Burt's Bees Serum with Bonicell
description: This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, Bonicel (Ganaden).
arm group label: Serum with Bonicell
intervention type: Other
intervention name: Burt's Bees Serum with Berenew Complex
description: This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, BeRenew CLR Complex (CLR).
arm group label: Serum with Berenew Complex
intervention type: Other
intervention name: Burt's Bees Serum with Ecoskin
description: This is a commercially available over-the-counter product. Ingredients: Caprylic/Capric Triglyceride, Dimer Dilinoleyl Dimer Dilionoleatem, Silica, Citronellyl Methylcrotonate, Tocopheryl Acetate, Xymenynic Acid, Alpha-glucan Oligosaccharide, Fragrance, Slareolide, Polymnia sonshifolia root juice, Helianthus annuus (sunflower) seed oil, Maltodextrin, Tocopherol, Beta-sitosterol, Lactobacillus, Squalene.
arm group label: Serum with Ecoskin
criteria: 
gender: Female
gender based: Yes
gender description: Females, aged 20-45
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No