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/NCT06022874</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00066042</org_study_id>
      <nct_id>NCT06022874</nct_id>
    </id_info>
    <brief_title>The Therapeutic Effects of Topical Cannabidiol (CBD) Products for Atopic Dermatitis</brief_title>
    <official_title>The Therapeutic Effects of Topical Cannabidiol (CBD) Products for Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Phoilex Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Phoenix Medical Spa X Peak Human</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Phoilex Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about the potential therapeutic effects of&#xD;
        topical CBD products produced by Phoilex Ltd., specifically the Releaf Gel, in those&#xD;
        diagnosed with atopic dermatitis. Patients will be routinely assessed via questionnaire, and&#xD;
        physical measurements will be taken with respect to the affected area studied in order to&#xD;
        judge clinical efficacy.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Did you experience an immediate increase in skin hydration?&#xD;
  &#xD;
          -  Did you experience a soothing or comforting feeling on your irritated skin area? Please&#xD;
             explain where your affected area is located, and also include at what time point this&#xD;
             occurred. Example: Affected Area: Palm, Time Point: 1-hour post-application&#xD;
  &#xD;
          -  Upon the affected area being in the healing phase, was your skin itch/scratch free for&#xD;
             4/6/10/12 hours (please circle)?&#xD;
  &#xD;
          -  Did you experience immediate relief from your skin inflammation?&#xD;
  &#xD;
          -  Did the study cream absorb quickly into your skin, without any greasy feeling?&#xD;
  &#xD;
          -  Has your skin flare disappeared in 2 week(s)?&#xD;
  &#xD;
          -  Has your skin condition appearance improved? (Yes/No)&#xD;
  &#xD;
        Participants will apply Phoilex Releaf Gel (a cream) to their affected areas of atopic&#xD;
        dermatitis. The questions listed above shall be discussed and observations recorded at the 0&#xD;
        week, 1 week, 2 week, and 4 week time points. Additional monitoring questions may be asked of&#xD;
        the participants to ensure the safety of the product. A chart will be provided to the&#xD;
        participants to track Phoilex Releaf Gel usage (how many pumps, and time of day) throughout&#xD;
        duration of the study.&#xD;
  &#xD;
        We hypothesize that Releaf gel will be suitable to ameliorate the common signs and symptoms&#xD;
        of atopic dermatitis as well as improve patient quality of life.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Will topically applied CBD be effective in reducing the appearance/clearing of atopic dermatitis after 4 weeks of study treatment?</measure>
      <time_frame>5 weeks</time_frame>
      <description>Outcome will be measured based on observations recorded at 0 weeks, 1 week, 2 week, and 4 week time point, not limited to physical assessment, clinical photography, and the responses of questions below:&#xD;
  Did you experience an immediate increase in skin hydration?&#xD;
  Did you experience a soothing or comforting feeling on your irritated skin area? Please explain where your affected area is located, and also include at what time point this occurred. Example: Affected Area: Palm, Time Point: 1-hour post-application&#xD;
  Upon the affected area being in the healing phase, was your skin itch/scratch free for 4/6/10/12 hours (please circle)?&#xD;
  Did you experience immediate relief from your skin inflammation?&#xD;
  Did the study cream absorb quickly into your skin, without any greasy feeling?&#xD;
  Has your skin flare disappeared in 2 week(s)?&#xD;
  Has your skin condition appearance improved? (Yes/No)</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>Patient's Diagnosed with Atopic Dermatitis</arm_group_label>
      <description>Patient's Diagnosed with Atopic Dermatitis</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Phoilex Releaf Gel</intervention_name>
      <description>Patients will be given the Releaf Gel to apply to the affected areas daily. They will be examined at the following time points: Immediately after application, 1 week, 2 weeks, and 4 weeks.&#xD;
  The instructions given to the patient shall be to apply one pump per every affected area, wash hands before applying to affected area, apply twice a day (morning, and evening), apply on clean skin, and application after showering is advised.&#xD;
  The number of pumps of Phoilex Releaf gel will be documented within a chart provided to the patient. It is suggested that not more than 25 lesions compassing an area greater than 50 cm² in total be treated during the course of this study.&#xD;
  The maximum dose would be 240 mL of Phoilex Releaf gel in 30 days. The minimum dose would be 0.5 mL (one pump) of the Phoilex Releaf gel in 30 days. The maximum daily dose of CBD per day 46 mg per application, equivalent to 92 mg per day.</description>
      <arm_group_label>Patient's Diagnosed with Atopic Dermatitis</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients diagnosed with moderate to severe atopic dermatitis will be selected and recruited&#xD;
          from medical clinics, social media, as well as invitation should they meet the inclusion&#xD;
          criteria. Participants must be able to travel to clinic location in Brampton.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Specifically, patients would be recruited based on the following inclusion criteria&#xD;
               must be over 18 years old and must be diagnosed with moderate-to-severe eczema.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion criteria would include not currently using any steroids or biologics, not&#xD;
               currently using any other topical products, not pregnant, not breast feeding, nor have&#xD;
               any allergies to any ingredients listed within the formula of the Releaf gel. A&#xD;
               negative pregnancy test will need to be confirmed prior to patient receiving Phoilex&#xD;
               Releaf Gel. Lastly, participants who have been diagnosed with anxiety or depression&#xD;
               with a classification of greater than mild anxiety or mild depression will be&#xD;
               excluded. As such, screening for possible candidates for the clinical trial will&#xD;
               include questions and a brief assessment on participants mental health by study&#xD;
               doctor/physician.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sanjeev Goel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Phoenix Medical Spa X Peak Human</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sanjeev Goel, MD</last_name>
      <phone>(647) 703-2085</phone>
      <email>drgoel@peakhuman.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sarina Pilaroscia</last_name>
      <email>info@phoilex.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Phoenix Medical Spa X Peak Human</name>
        <address>
          <city>Brampton</city>
          <state>Ontario</state>
          <zip>L6W 3E1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Michelle Rodrigues</last_name>
        <phone>(647) 703-2085</phone>
        <email>michelle@peakhuman.ca</email>
      </contact>
      <investigator>
        <last_name>Sanjeev Goel, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dermatitis, Atopic</mesh_term>
      <mesh_term>Dermatitis</mesh_term>
      <mesh_term>Eczema</mesh_term>
    </condition_browse>
    <!-- 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/NCT06022874
  org study id: Pro00066042
  nct id: NCT06022874
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the potential therapeutic effects of
        topical CBD products produced by Phoilex Ltd., specifically the Releaf Gel, in those
        diagnosed with atopic dermatitis. Patients will be routinely assessed via questionnaire, and
        physical measurements will be taken with respect to the affected area studied in order to
        judge clinical efficacy.
  
        The main question[s] it aims to answer are:
  
          -  Did you experience an immediate increase in skin hydration?
  
          -  Did you experience a soothing or comforting feeling on your irritated skin area? Please
             explain where your affected area is located, and also include at what time point this
             occurred. Example: Affected Area: Palm, Time Point: 1-hour post-application
  
          -  Upon the affected area being in the healing phase, was your skin itch/scratch free for
             4/6/10/12 hours (please circle)?
  
          -  Did you experience immediate relief from your skin inflammation?
  
          -  Did the study cream absorb quickly into your skin, without any greasy feeling?
  
          -  Has your skin flare disappeared in 2 week(s)?
  
          -  Has your skin condition appearance improved? (Yes/No)
  
        Participants will apply Phoilex Releaf Gel (a cream) to their affected areas of atopic
        dermatitis. The questions listed above shall be discussed and observations recorded at the 0
        week, 1 week, 2 week, and 4 week time points. Additional monitoring questions may be asked of
        the participants to ensure the safety of the product. A chart will be provided to the
        participants to track Phoilex Releaf Gel usage (how many pumps, and time of day) throughout
        duration of the study.
  
        We hypothesize that Releaf gel will be suitable to ameliorate the common signs and symptoms
        of atopic dermatitis as well as improve patient quality of life.
  observational model: Case-Only
  time perspective: Prospective
  measure: Will topically applied CBD be effective in reducing the appearance/clearing of atopic dermatitis after 4 weeks of study treatment?
  time frame: 5 weeks
  description: Outcome will be measured based on observations recorded at 0 weeks, 1 week, 2 week, and 4 week time point, not limited to physical assessment, clinical photography, and the responses of questions below:
  Did you experience an immediate increase in skin hydration?
  Did you experience a soothing or comforting feeling on your irritated skin area? Please explain where your affected area is located, and also include at what time point this occurred. Example: Affected Area: Palm, Time Point: 1-hour post-application
  Upon the affected area being in the healing phase, was your skin itch/scratch free for 4/6/10/12 hours (please circle)?
  Did you experience immediate relief from your skin inflammation?
  Did the study cream absorb quickly into your skin, without any greasy feeling?
  Has your skin flare disappeared in 2 week(s)?
  Has your skin condition appearance improved? (Yes/No)
  arm group label: Patient's Diagnosed with Atopic Dermatitis
  description: Patient's Diagnosed with Atopic Dermatitis
  intervention type: Other
  intervention name: Phoilex Releaf Gel
  description: Patients will be given the Releaf Gel to apply to the affected areas daily. They will be examined at the following time points: Immediately after application, 1 week, 2 weeks, and 4 weeks.
  The instructions given to the patient shall be to apply one pump per every affected area, wash hands before applying to affected area, apply twice a day (morning, and evening), apply on clean skin, and application after showering is advised.
  The number of pumps of Phoilex Releaf gel will be documented within a chart provided to the patient. It is suggested that not more than 25 lesions compassing an area greater than 50 cm² in total be treated during the course of this study.
  The maximum dose would be 240 mL of Phoilex Releaf gel in 30 days. The minimum dose would be 0.5 mL (one pump) of the Phoilex Releaf gel in 30 days. The maximum daily dose of CBD per day 46 mg per application, equivalent to 92 mg per day.
  arm group label: Patient's Diagnosed with Atopic Dermatitis
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sanjeev Goel, MD
  role: Principal Investigator
  affiliation: Phoenix Medical Spa X Peak Human
  last name: Sanjeev Goel, MD
  phone: (647) 703-2085
  email: drgoel@peakhuman.ca
  last name: Sarina Pilaroscia
  email: info@phoilex.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema