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/NCT06015217</url>
    </required_header>
    <id_info>
      <org_study_id>GLI.04.US.SL.027</org_study_id>
      <nct_id>NCT06015217</nct_id>
    </id_info>
    <brief_title>A Clinical Study to Assess the Efficacy and Safety of a Healing Ointment on Diaper Rash</brief_title>
    <official_title>An Open-label Study to Assess Efficacy and Safety of a Healing Ointment When Used on Infants With Mild-to-moderate Diaper Rash</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Galderma R&amp;D</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Young Skin MD</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Galderma R&amp;D</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to assess the efficacy and safety of a Healing Ointment in&#xD;
        infants 2-24 months with mild to moderate diaper rash. The main question it aims to answer&#xD;
        is:&#xD;
  &#xD;
        • does a Healing Ointment improve skin texture and smoothness in infants with mild to&#xD;
        moderate diaper dermatitis? Participants will use a Healing Ointment on the diaper area with&#xD;
        every diaper change, have the Investigator perform efficacy and tolerability assessments, and&#xD;
        complete questionnaires regarding subject satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">September 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 29, 2023</primary_completion_date>
    <phase>Phase 4</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>
      <intervention_model_description>This study only has a single group, and all subjects receive the same treatment.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Product Efficacy</measure>
      <time_frame>Week 1, Week 3</time_frame>
      <description>Product efficacy will be measured by Investigator's evaluation of skin's tactile smoothness, visual skin texture, and diaper dermatitis. Skin smoothness (tactile) and skin texture will be measured on a 10-point modified Griffith's scale, where 0 is the best possible condition and 9 is the worst possible condition, and diaper dermatitis will be measured on a 5-point scale, where 0 is the best possible condition and 4 is the worst possible condition. A decrease in scores indicates an improvement.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Subject Satisfaction</measure>
      <time_frame>Day 1, Week 1, Week 3</time_frame>
      <description>To evaluate subject satisfaction using a Self-Assessment Questionnaire. Questionnaires will be tabulated; and the frequency and percentage of all response options will be reported for each question and time point. For questionnaire inquiries without baseline response data, a binomial (sign) test will be performed to test if the proportion of the combined designated favorable responses is equal to the combined designated unfavorable responses for each applicable question. A higher percentage of favorable responses with a significant p value indicates positive subject perceptions of the study treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Product Tolerability</measure>
      <time_frame>Week 1, Week 3</time_frame>
      <description>Product tolerability will be measured by Investigator's evaluation of dryness, peeling, and edema on a 4-point analog scale, with half-point scores used as necessary to better describe the clinical condition, where 0 indicates parameter is not present and 3 indicates parameter is severe. A decrease in scores or lack of significant increase indicates tolerability/safety of the treatment product.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Diaper Rash</condition>
    <arm_group>
      <arm_group_label>Treatment Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All subjects have mild to moderate diaper dermatitis and are given &quot;Cetaphil Healing Ointment&quot; to use with every diaper change.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>&quot;Cetaphil Healing Ointment&quot;</intervention_name>
      <description>Subjects will use &quot;Cetaphil Healing Ointment&quot; on the diaper rash area with every diaper change</description>
      <arm_group_label>Treatment Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The subjects must meet all the following criteria to be eligible for the study:&#xD;
  &#xD;
                 1. Infant subjects aged 2 months to 24 months&#xD;
  &#xD;
                 2. Females and males&#xD;
  &#xD;
                 3. All Fitzpatrick skin types I-VI&#xD;
  &#xD;
                 4. All races and ethnicities&#xD;
  &#xD;
                 5. Subject diagnosed with mild-to-moderate diaper rash&#xD;
  &#xD;
                 6. Subject with healthy immune systems&#xD;
  &#xD;
                 7. Willing to be photographed at each visit (optional)&#xD;
  &#xD;
                 8. Willing to abstain from use of any other topical diaper rash treatments&#xD;
                    (ointments, moisturizers, emollients, creams, and wipes) other than the assigned&#xD;
                    test product and skincare products that have been routinely used on the diaper&#xD;
                    area during the duration of the study&#xD;
  &#xD;
                 9. Willing to continue using regular brands of face/body cleanser and not to begin&#xD;
                    use of any new skincare products other than the test product for the duration of&#xD;
                    the study&#xD;
  &#xD;
                10. Parent/legal guardian/legal guardians must be at least 18 years old and are&#xD;
                    willing and able to present proof of legal guardianship&#xD;
  &#xD;
                11. Parent/legal guardian/legal guardian with ability to read, understand and give&#xD;
                    consent for participation in the study&#xD;
  &#xD;
                12. Parent/legal guardians/legal guardians willing to sign a photography release form&#xD;
  &#xD;
                13. Parent/legal guardian/guardian must agree to adhere to the procedures and&#xD;
                    requirements of the study and to report to the site on the day(s) and at the&#xD;
                    time(s) scheduled for the assessments&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The presence of any of the following exclusion criteria excluded a subject from&#xD;
               enrollment in the study:&#xD;
  &#xD;
                 1. Subject diagnosed with severe diaper rash&#xD;
  &#xD;
                 2. History of allergy or hypersensitivity to any ingredient of the test product&#xD;
  &#xD;
                 3. Presence of any disease or lesions near or on the area to be treated, e.g.,&#xD;
  &#xD;
                      1. Inflammation, active, or chronic infection in or near the treatment area&#xD;
  &#xD;
                      2. Psoriasis, eczema, rosacea, atopic dermatitis, herpes zoster/herpes simplex,&#xD;
                         and acanthosis&#xD;
  &#xD;
                      3. Scars or deformities&#xD;
  &#xD;
                 4. History of coexisting bacterial infections or medical conditions with&#xD;
                    uncontrolled gastrointestinal diseases and/or bowel movements&#xD;
  &#xD;
                 5. History of severe elastosis and/or excessive sun exposure that, in the opinion of&#xD;
                    the Investigator, could have affected the outcome of the study&#xD;
  &#xD;
                 6. Planning on having surgeries and/or invasive medical procedures during the course&#xD;
                    of the study&#xD;
  &#xD;
                 7. Treatment with chemotherapy, immunosuppressive agents, inhaled corticosteroids,&#xD;
                    immunomodulatory therapy (e.g., monoclonal antibodies or antiviral treatment for&#xD;
                    human immunodeficiency virus or hepatitis C)&#xD;
  &#xD;
                 8. Current use of topical corticosteroids, topical prescription, or oral antibiotics&#xD;
                    in the treatment area, or use within last 2 weeks&#xD;
  &#xD;
                 9. Current use of over-the counter topical medications for diaper rash&#xD;
  &#xD;
                10. History of cancer or previous radiation near or on the treatment area&#xD;
  &#xD;
                11. Human immunodeficiency virus positive or active hepatitis&#xD;
  &#xD;
                12. Presence of dermal markings on or near the treatment area that, in the opinion of&#xD;
                    the Investigator, will interfere with the clinical assessments&#xD;
  &#xD;
                13. Any medical condition that, in the opinion of the Investigator, would make the&#xD;
                    subject unsuitable for inclusion (e.g., a chronic or relapsing, disease that may&#xD;
                    interfere with the outcome of the study)&#xD;
  &#xD;
                14. Other condition preventing the subject from entering the study in the&#xD;
                    Investigator's opinion, (e.g., subjects failing baseline assessments, subjects&#xD;
                    not likely to avoid other cosmetic treatments in the treatment area, subjects&#xD;
                    anticipated to be unavailable or incapable of understanding the study assessments&#xD;
                    or having unrealistic expectations of the treatment result).&#xD;
  &#xD;
                15. Study site personnel, close relatives of the study site personnel (e.g.,&#xD;
                    parent/legal guardians, children, siblings, or spouse), or employees and close&#xD;
                    relatives of employees at the Sponsor company.&#xD;
  &#xD;
                16. Participation in any interventional clinical study within 30 days of screening&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Months</minimum_age>
      <maximum_age>24 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Latanya Benjamin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Young Skin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sindhu Garimella</last_name>
      <phone>2146909747</phone>
      <email>sindhu.garimella@galderma.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thu Nguyen</last_name>
      <email>thu.nguyen@galderma.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Young Skin MD</name>
        <address>
          <city>Coral Springs</city>
          <state>Florida</state>
          <zip>33067</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Latanya Benjamin</last_name>
        <phone>954-242-4275</phone>
        <email>drmommy22@icloud.com</email>
      </contact>
      <investigator>
        <last_name>Latanya Benjamin</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 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>Diaper Rash</mesh_term>
    </condition_browse>
    <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/NCT06015217
  org study id: GLI.04.US.SL.027
  nct id: NCT06015217
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical trial is to assess the efficacy and safety of a Healing Ointment in
        infants 2-24 months with mild to moderate diaper rash. The main question it aims to answer
        is:
  
        • does a Healing Ointment improve skin texture and smoothness in infants with mild to
        moderate diaper dermatitis? Participants will use a Healing Ointment on the diaper area with
        every diaper change, have the Investigator perform efficacy and tolerability assessments, and
        complete questionnaires regarding subject satisfaction.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This study only has a single group, and all subjects receive the same treatment.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Product Efficacy
  time frame: Week 1, Week 3
  description: Product efficacy will be measured by Investigator's evaluation of skin's tactile smoothness, visual skin texture, and diaper dermatitis. Skin smoothness (tactile) and skin texture will be measured on a 10-point modified Griffith's scale, where 0 is the best possible condition and 9 is the worst possible condition, and diaper dermatitis will be measured on a 5-point scale, where 0 is the best possible condition and 4 is the worst possible condition. A decrease in scores indicates an improvement.
  measure: Subject Satisfaction
  time frame: Day 1, Week 1, Week 3
  description: To evaluate subject satisfaction using a Self-Assessment Questionnaire. Questionnaires will be tabulated; and the frequency and percentage of all response options will be reported for each question and time point. For questionnaire inquiries without baseline response data, a binomial (sign) test will be performed to test if the proportion of the combined designated favorable responses is equal to the combined designated unfavorable responses for each applicable question. A higher percentage of favorable responses with a significant p value indicates positive subject perceptions of the study treatment.
  measure: Product Tolerability
  time frame: Week 1, Week 3
  description: Product tolerability will be measured by Investigator's evaluation of dryness, peeling, and edema on a 4-point analog scale, with half-point scores used as necessary to better describe the clinical condition, where 0 indicates parameter is not present and 3 indicates parameter is severe. A decrease in scores or lack of significant increase indicates tolerability/safety of the treatment product.
  arm group label: Treatment Group
  arm group type: Experimental
  description: All subjects have mild to moderate diaper dermatitis and are given "Cetaphil Healing Ointment" to use with every diaper change.
  intervention type: Drug
  intervention name: "Cetaphil Healing Ointment"
  description: Subjects will use "Cetaphil Healing Ointment" on the diaper rash area with every diaper change
  arm group label: Treatment Group
  criteria: 
  gender: All
  minimum age: 2 Months
  maximum age: 24 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Latanya Benjamin
  role: Principal Investigator
  affiliation: Young Skin
  last name: Sindhu Garimella
  phone: 2146909747
  email: sindhu.garimella@galderma.com
  last name: Thu Nguyen
  email: thu.nguyen@galderma.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Diaper Rash
  sharing ipd: No