xml: <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/NCT06020248</url>
    </required_header>
    <id_info>
      <org_study_id>22-37861</org_study_id>
      <nct_id>NCT06020248</nct_id>
    </id_info>
    <brief_title>Melanin and Dermal Uptake of Thirdhand Cigarette Smoke</brief_title>
    <acronym>THS05</acronym>
    <official_title>Melanin and Dermal Uptake of Thirdhand Cigarette Smoke</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Francisco</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 pilot study of the effects of dermal melanin on dermal uptake and retention of&#xD;
        nicotine. The initial hypothesis is that higher levels of dermal melanin will correlate with&#xD;
        lower uptake and longer retention of nicotine in the skin and body.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an interventional pharmacokinetic study comparing the uptake and metabolism of&#xD;
        nicotine from smoke-exposed clothing in people with low high levels of dermal melanin and&#xD;
        people with high levels of dermal melanin. The study will measure nicotine and metabolites of&#xD;
        nicotine in the blood during exposure and in urine for 10 days after exposure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Dermal uptake, metabolism and excretion of nicotine in participants with high and low levels of dermal melanin will be compared.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Smoke exposure is impossible to mask and team is too small to mask data analysis until later stages.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in blood concentrations of nicotine</measure>
      <time_frame>Baseline and 3 hours</time_frame>
      <description>The study will measure concentration of nicotine in the blood before and after the dermal exposure to nicotine.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine</measure>
      <time_frame>First void, collected for 10 days</time_frame>
      <description>The study will measure urinary metabolites of nicotine in the first void of the day for 10 days after exposure and sum the total mass of metabolites.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Urinary concentration of the NNK metabolite NNAL</measure>
      <time_frame>First void, collected for 10 days</time_frame>
      <description>The study will measure urinary metabolites of NNK in the first void of the day for 10 days after exposure and sum the total mass of metabolites.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Low melanin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals with skin reflectance scores below 150 using the Mexameter 18 instrument.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High melanin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Individuals with skin reflectance scores above 249 using the Mexameter 18 instrument</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Wear clothing that has been exposed to cigarette smoke for 3 hours.</intervention_name>
      <description>Cotton clothing is exposed to smoke from Marlboro Red (hard pack) cigarettes at 1-1.2 mg/m3 repeatedly, until total exposure equals 3 grams total particulate material. When tested after exposure, the clothing typically contained 59.15 +/- 18 µg nicotine and 42 +/- 24 ng NNK per gram. The mass of the clothing varies by size, but the average combination of pants and shirt contains 32 mgs nicotine and 23 µg NNK.</description>
      <arm_group_label>High melanin</arm_group_label>
      <arm_group_label>Low melanin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult nonsmoker&#xD;
  &#xD;
            -  Aged 18-50&#xD;
  &#xD;
            -  Skin reflectance scores below 150 or above 249 using the Mexameter 18 instrument&#xD;
  &#xD;
            -  Healthy on the basis of medical history&#xD;
  &#xD;
            -  Systolic blood pressure &lt;150&#xD;
  &#xD;
            -  Diastolic blood pressure &lt;100&#xD;
  &#xD;
            -  C-reactive protein &lt;3.1 mg/ml&#xD;
  &#xD;
            -  Liver function (AST and ALT) in normal ranges&#xD;
  &#xD;
            -  kidney function (BUN) in normal ranges&#xD;
  &#xD;
            -  LDL&lt;131&#xD;
  &#xD;
            -  Blood glucose &lt;110&#xD;
  &#xD;
            -  Not exposed to tobacco SHS.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dermal skin reflectance score between 150 and 249, as measured by the Mexameter 18&#xD;
               instrument.&#xD;
  &#xD;
            -  Positive SARS-CoV-2 antibody test&#xD;
  &#xD;
            -  Age 18 &lt; or &gt; 50&#xD;
  &#xD;
            -  Physician diagnosis of asthma, heart disease, hypertension, thyroid disease, diabetes,&#xD;
               renal or liver impairment or glaucoma.&#xD;
  &#xD;
            -  Unstable psychiatric condition (such as current major depression, history of&#xD;
               schizophrenia or bipolar disorder) or current use of more than two psychiatric&#xD;
               medications&#xD;
  &#xD;
            -  Systolic blood pressure greater than or equal to 150&#xD;
  &#xD;
            -  Diastolic blood pressure greater than or equal to 100&#xD;
  &#xD;
            -  Blood glucose greater than or equal to 110&#xD;
  &#xD;
            -  LDL greater than or equal to130&#xD;
  &#xD;
            -  Pregnancy or breastfeeding (by urine hCG and/or history)&#xD;
  &#xD;
            -  Alcohol or illicit drug dependence within the past 5 years&#xD;
  &#xD;
            -  BMI &gt; 35 and &lt; 18&#xD;
  &#xD;
            -  Current illicit drug use (by history or urine test)&#xD;
  &#xD;
            -  More than 1 pack year smoking history&#xD;
  &#xD;
            -  Ever a daily marijuana smoker&#xD;
  &#xD;
            -  Smoked anything within the last 3 months&#xD;
  &#xD;
            -  Unable to hold allergy or other OTC medicines&#xD;
  &#xD;
            -  Occupational exposure to smoke, dusts OR fumes&#xD;
  &#xD;
            -  Concurrent participation in another clinical trial&#xD;
  &#xD;
            -  Unable to communicate in English&#xD;
  &#xD;
            -  No social security number&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Suzaynn F Schick, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suzaynn F Schick, PhD</last_name>
      <phone>415-514-3535</phone>
      <email>suzaynn@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Abel Huang, BS</last_name>
      <phone>(415) 514-9011</phone>
      <email>abel.huang@ucsf.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zuckerberg San Francisco General Hospital</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94110</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Thirdhand tobacco smoke</keyword>
    <keyword>Dermal</keyword>
    <keyword>Exposure</keyword>
    <keyword>Tobacco Smoke Pollution</keyword>
    <keyword>Melanin</keyword>
    <keyword>Nicotine</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020248
  org study id: 22-37861
  nct id: NCT06020248
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a pilot study of the effects of dermal melanin on dermal uptake and retention of
        nicotine. The initial hypothesis is that higher levels of dermal melanin will correlate with
        lower uptake and longer retention of nicotine in the skin and body.
  This is an interventional pharmacokinetic study comparing the uptake and metabolism of
        nicotine from smoke-exposed clothing in people with low high levels of dermal melanin and
        people with high levels of dermal melanin. The study will measure nicotine and metabolites of
        nicotine in the blood during exposure and in urine for 10 days after exposure.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Dermal uptake, metabolism and excretion of nicotine in participants with high and low levels of dermal melanin will be compared.
  primary purpose: Basic Science
  masking: None (Open Label)
  masking description: Smoke exposure is impossible to mask and team is too small to mask data analysis until later stages.
  measure: Change in blood concentrations of nicotine
  time frame: Baseline and 3 hours
  description: The study will measure concentration of nicotine in the blood before and after the dermal exposure to nicotine.
  measure: Total combined urinary concentrations of the nicotine metabolites cotinine and 3-hydroxycotinine
  time frame: First void, collected for 10 days
  description: The study will measure urinary metabolites of nicotine in the first void of the day for 10 days after exposure and sum the total mass of metabolites.
  measure: Urinary concentration of the NNK metabolite NNAL
  time frame: First void, collected for 10 days
  description: The study will measure urinary metabolites of NNK in the first void of the day for 10 days after exposure and sum the total mass of metabolites.
  arm group label: Low melanin
  arm group type: Experimental
  description: Individuals with skin reflectance scores below 150 using the Mexameter 18 instrument.
  arm group label: High melanin
  arm group type: Experimental
  description: Individuals with skin reflectance scores above 249 using the Mexameter 18 instrument
  intervention type: Other
  intervention name: Wear clothing that has been exposed to cigarette smoke for 3 hours.
  description: Cotton clothing is exposed to smoke from Marlboro Red (hard pack) cigarettes at 1-1.2 mg/m3 repeatedly, until total exposure equals 3 grams total particulate material. When tested after exposure, the clothing typically contained 59.15 +/- 18 µg nicotine and 42 +/- 24 ng NNK per gram. The mass of the clothing varies by size, but the average combination of pants and shirt contains 32 mgs nicotine and 23 µg NNK.
  arm group label: High melanin
  arm group label: Low melanin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Suzaynn F Schick, PhD
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Suzaynn F Schick, PhD
  phone: 415-514-3535
  email: suzaynn@gmail.com
  last name: Abel Huang, BS
  phone: (415) 514-9011
  email: abel.huang@ucsf.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No