<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/NCT04476732</url>
  </required_header>
  <id_info>
    <org_study_id>1529276</org_study_id>
    <nct_id>NCT04476732</nct_id>
  </id_info>
  <brief_title>Interactions Between Skincare Product Ingredients and the Skin Microbiome</brief_title>
  <official_title>Interactions Between Skincare Product Ingredients and 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>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>
      This is a study of the influence of skincare products containing chemicals such as parabens&#xD;
      and phthalates on the skin microbiome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Skin serves as a critical barrier between our bodies and the environment and the locus for a&#xD;
      diverse and active microbial community. The composition and metabolic activity of the&#xD;
      microbial community on the skin is presumably influenced by the local chemical environment,&#xD;
      which includes natural skin lipids (e.g., squalene and sapienic acid), components of personal&#xD;
      care products applied directly to skin, and semi-volatile organic compounds (SVOCs) that&#xD;
      reach the skin through gas phase absorption, dust deposition, and direct contact with&#xD;
      surfaces. Common semi-volatile ingredients in skin care products include phthalates,&#xD;
      parabens, and UV blocking compounds (e.g., oxybenzone, octocrylene or homosalate).&#xD;
&#xD;
      The investigators have recently demonstrated a method of collecting chemicals from areas of&#xD;
      skin with infrequent direct dermal contact using alcohol wipes to assess passive air to skin&#xD;
      partitioning of both target and nontarget compounds (Garrido et al., in review).&#xD;
      Low-volatility reaction products can accumulate in skin oils and act as skin irritants, with&#xD;
      the potential of being absorbed into the bloodstream. With methods developed for chemical and&#xD;
      microbiome sampling, the overall goal of the proposed research is to develop an understanding&#xD;
      of the two-way interaction between organic chemicals on the skin and the composition of the&#xD;
      skin microbiome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2020</start_date>
  <completion_date type="Actual">July 16, 2020</completion_date>
  <primary_completion_date type="Actual">July 16, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in detected paraben levels</measure>
    <time_frame>Baseline, 1 week, 2 weeks</time_frame>
    <description>Demonstrate the ability to detect chemicals (specifically parabens) found in common ingredients in personal care products on human skin. Collection of isopropyl alcohol forehead wipe and subsequent detection and quantification of parabens by GC-QTOF-MS (gas chromatography) and LC-QTOF-MS (liquid chromatography). Comparisons between baseline, week 1, and week 2 will be made.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence of skincare product ingredient (specifically parabens) on facial skin microbiome</measure>
    <time_frame>Baseline, 1 week, 2 weeks</time_frame>
    <description>Document changes in microbial community composition following application of skin care ingredients of controversial concern (parabens) in comparison with changes following application of products not containing these ingredients. This is assessed by facial swab collections, DNA extraction, and determination of a list of specific bacterial species present at each time point. Comparisons between baseline, week 1, and week 2 will be made.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Dysbiosis</condition>
  <arm_group>
    <arm_group_label>Paraben-free then Paraben-containing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paraben free facial lotion is applied twice a day for 1 week and measurements are taken. Then, paraben-containing facial lotion is applied twice a day for 1 week and measurements are taken.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Paraben-free skincare product</intervention_name>
    <description>Paraben-free lotion will be applied twice a day for one week.</description>
    <arm_group_label>Paraben-free then Paraben-containing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Paraben-containing skincare product</intervention_name>
    <description>Paraben-containing lotion will be applied twice a day for one week.</description>
    <arm_group_label>Paraben-free then Paraben-containing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals aged 15 and over&#xD;
&#xD;
          -  No known medical conditions that, in the investigator's opinion, may interfere with&#xD;
             study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who have been on any medication (including antibiotics, probiotics,&#xD;
             prebiotics) that has caused a change in current skin composition of interest based on&#xD;
             the opinion of the investigator.&#xD;
&#xD;
          -  Individuals with systemic antibiotic use within last 60 days.&#xD;
&#xD;
          -  Individuals with topical antibiotic use on the test sites within last 30 days&#xD;
&#xD;
          -  Individuals unwilling/unable to avoid topical antibiotics, systemic antibiotics,&#xD;
             prebiotics, and probiotics during study.&#xD;
&#xD;
          -  No other interfering skin products should be used during duration of study.&#xD;
             (Paraben-free &amp; phthalate-free personal product &quot;safe&quot; list will be provided for other&#xD;
             uses during study period if needed).&#xD;
&#xD;
          -  Individuals unwilling or unable to undergo 1 week wash-in with paraben/phthalate-free&#xD;
             products if needed in the opinion of the investigator.&#xD;
&#xD;
          -  Female volunteers who are pregnant or are actively breastfeeding or planning a&#xD;
             pregnancy within two months. (There is no known concern for risk to fetus but&#xD;
             pregnancy can alter the microbiome being studied)&#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 using any interfering skin products in the opinion of the investigator&#xD;
             within 2 weeks of enrollment into the study.&#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;
          -  Individuals with a known history of hypersensitivity to any ingredients to the&#xD;
             cosmetic agent that is being assessed&#xD;
&#xD;
          -  Individuals who have history of a psychological illness or condition that would&#xD;
             interfere with their ability to understand and follow the requirements of the study at&#xD;
             the discretion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raja K Sivamani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UC Davis Dermatology Clinical Trials Unit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis Dermatology Department</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>microbiome</keyword>
  <keyword>skincare</keyword>
  <keyword>skin</keyword>
  <keyword>paraben</keyword>
  <keyword>phthalate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysbiosis</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/NCT04476732
org study id: 1529276
nct id: NCT04476732
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study of the influence of skincare products containing chemicals such as parabens
      and phthalates on the skin microbiome.
Skin serves as a critical barrier between our bodies and the environment and the locus for a
      diverse and active microbial community. The composition and metabolic activity of the
      microbial community on the skin is presumably influenced by the local chemical environment,
      which includes natural skin lipids (e.g., squalene and sapienic acid), components of personal
      care products applied directly to skin, and semi-volatile organic compounds (SVOCs) that
      reach the skin through gas phase absorption, dust deposition, and direct contact with
      surfaces. Common semi-volatile ingredients in skin care products include phthalates,
      parabens, and UV blocking compounds (e.g., oxybenzone, octocrylene or homosalate).

      The investigators have recently demonstrated a method of collecting chemicals from areas of
      skin with infrequent direct dermal contact using alcohol wipes to assess passive air to skin
      partitioning of both target and nontarget compounds (Garrido et al., in review).
      Low-volatility reaction products can accumulate in skin oils and act as skin irritants, with
      the potential of being absorbed into the bloodstream. With methods developed for chemical and
      microbiome sampling, the overall goal of the proposed research is to develop an understanding
      of the two-way interaction between organic chemicals on the skin and the composition of the
      skin microbiome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in detected paraben levels
time frame: Baseline, 1 week, 2 weeks
description: Demonstrate the ability to detect chemicals (specifically parabens) found in common ingredients in personal care products on human skin. Collection of isopropyl alcohol forehead wipe and subsequent detection and quantification of parabens by GC-QTOF-MS (gas chromatography) and LC-QTOF-MS (liquid chromatography). Comparisons between baseline, week 1, and week 2 will be made.
measure: Influence of skincare product ingredient (specifically parabens) on facial skin microbiome
time frame: Baseline, 1 week, 2 weeks
description: Document changes in microbial community composition following application of skin care ingredients of controversial concern (parabens) in comparison with changes following application of products not containing these ingredients. This is assessed by facial swab collections, DNA extraction, and determination of a list of specific bacterial species present at each time point. Comparisons between baseline, week 1, and week 2 will be made.
arm group label: Paraben-free then Paraben-containing
arm group type: Experimental
description: Paraben free facial lotion is applied twice a day for 1 week and measurements are taken. Then, paraben-containing facial lotion is applied twice a day for 1 week and measurements are taken.
intervention type: Other
intervention name: Paraben-free skincare product
description: Paraben-free lotion will be applied twice a day for one week.
arm group label: Paraben-free then Paraben-containing
intervention type: Other
intervention name: Paraben-containing skincare product
description: Paraben-containing lotion will be applied twice a day for one week.
arm group label: Paraben-free then Paraben-containing
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Raja K Sivamani, MD
role: Principal Investigator
affiliation: UC Davis Dermatology Clinical Trials Unit
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dysbiosis
sharing ipd: No