<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/NCT03830177</url>
  </required_header>
  <id_info>
    <org_study_id>2019-2309</org_study_id>
    <nct_id>NCT03830177</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult</brief_title>
  <official_title>Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwestern University Feinberg School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ann &amp; Robert H Lurie Children's Hospital of Chicago</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if a topical treatment for dry scalp conditions, is&#xD;
      safe and effective in clinically improving dry scalp conditions. The investigators will&#xD;
      additionally examine individuals experience in using the treatment as well as any changes in&#xD;
      the scalp microbiome before and after use studying the treatment , the investigators hope to&#xD;
      offer children and adults a new, natural way to improve dry scalp conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 6, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety/patients comfort of the product using Overall Safety Score assessment, a 4 point assessment.</measure>
    <time_frame>6 months</time_frame>
    <description>Safety will be determined by contacting the patient via text over the phone and through a daily journal designed to document adverse events and Overall Safety Score. The Overall Safety Score and the reporting of adverse events throughout the study will measure the safety of the treatment. The Overall Safety Score is a 4-point assessment ranging from &quot;no signs of irritation&quot; (0) to &quot;patient discontinued due to irritation&quot; (3).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement of patients erythema, scaling, and pruritus</measure>
    <time_frame>6 months</time_frame>
    <description>Efficacy will be determined using the Investigator's Global Assessment (IGA) scale, a 5-point assessment ranging from clear (0) to severe disease (4) and the Total Severity Scale (TSS), an assessment that averages erythema, scaling, and pruritus severity scores of scalp lesions. The TSS uses a 4-point scale ranging from none (0) to severe (3).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in bacterial composition of scalp using RODAC</measure>
    <time_frame>6 months</time_frame>
    <description>An exploratory aim of this study is to find whether the natural treatment changes the microbiome after use for a dry scalp condition to more closely resemble healthy scalps. This will be accomplished by obtaining swab samples from the participants' scalps, before and after the treatment period. The samples will be analyzed using 16s RNA sequencing and internal transcribed spacer (ITS) sequencing. Additionally, the change in colony count of bacterial and fungal colonies on the scalp before and after the treatment will be assessed using the Replicate Organism Detection and Counting (RODAC) method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life change</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life will be calculated using the ScalpDex tool, a validated 23-item instrument that explains the way that patients with scalp dermatitis are affected by symptoms, functioning, and emotions.The scale is the Scalpdex quality of life instrument and asks questions about everyday activities such as wearing black clothes to itching. For the scale,the higher the score, the worse the outcome for the patient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dermatitis, Seborrheic</condition>
  <condition>Dry Skin; Eczema</condition>
  <arm_group>
    <arm_group_label>Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All adults in the study will receive the treatment for dry scalp.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All children in the study will receive the treatment for dry scalp.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Natural Treatment</intervention_name>
    <description>The participant will be given the treatment, which contains all natural ingredients, and a kit of all necessary materials to take home with them, which will include a set of instructions. The kit will contain the instruction handout and their treatment. They will be instructed to apply the treatment to their scalp, wait seven minutes, and then rinse their scalp. They will perform this entire procedure once per day for 14 days.</description>
    <arm_group_label>Adults</arm_group_label>
    <arm_group_label>Children</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 1 year (or corrected age of 1 year, for those born prematurely) to 11 years for&#xD;
             children (those who turn 12 over the study period will not be enrolled), and 18 and&#xD;
             older&#xD;
&#xD;
          2. Diagnosed with a dry scalp condition with and IGA score of 2 of greater by a&#xD;
             board-certified Dermatologist, Allergist, or Pediatrician&#xD;
&#xD;
          3. Good general health&#xD;
&#xD;
          4. Participant and/or their parent are able to read, write, and understand study&#xD;
             materials in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Infants younger than 1 year old and between the ages of 12 and 18 (those who turn 12&#xD;
             over the study period will not be enrolled)&#xD;
&#xD;
          2. Patients diagnosed with other scalp diseases such as psoriasis, tinea capitis, and&#xD;
             pediculosis capitis&#xD;
&#xD;
          3. Systemic steroid or oral antibiotic use during the past two months&#xD;
&#xD;
          4. Allergy to any of the preparation components&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lucy Bilaver, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Feinberg School of Medicine- Northwestern</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer R Long</last_name>
    <phone>6306641231</phone>
    <email>jennifer.long@northwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ruchi Gupta, MD, MPH</last_name>
    <phone>3125233533</phone>
    <email>r-gupta@northwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical Dermatology Associates of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60654</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Lio, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2021</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</mesh_term>
    <mesh_term>Dermatitis, Seborrheic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03830177
org study id: 2019-2309
nct id: NCT03830177
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine if a topical treatment for dry scalp conditions, is
      safe and effective in clinically improving dry scalp conditions. The investigators will
      additionally examine individuals experience in using the treatment as well as any changes in
      the scalp microbiome before and after use studying the treatment , the investigators hope to
      offer children and adults a new, natural way to improve dry scalp conditions.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety/patients comfort of the product using Overall Safety Score assessment, a 4 point assessment.
time frame: 6 months
description: Safety will be determined by contacting the patient via text over the phone and through a daily journal designed to document adverse events and Overall Safety Score. The Overall Safety Score and the reporting of adverse events throughout the study will measure the safety of the treatment. The Overall Safety Score is a 4-point assessment ranging from "no signs of irritation" (0) to "patient discontinued due to irritation" (3).
measure: Improvement of patients erythema, scaling, and pruritus
time frame: 6 months
description: Efficacy will be determined using the Investigator's Global Assessment (IGA) scale, a 5-point assessment ranging from clear (0) to severe disease (4) and the Total Severity Scale (TSS), an assessment that averages erythema, scaling, and pruritus severity scores of scalp lesions. The TSS uses a 4-point scale ranging from none (0) to severe (3).
measure: Change in bacterial composition of scalp using RODAC
time frame: 6 months
description: An exploratory aim of this study is to find whether the natural treatment changes the microbiome after use for a dry scalp condition to more closely resemble healthy scalps. This will be accomplished by obtaining swab samples from the participants' scalps, before and after the treatment period. The samples will be analyzed using 16s RNA sequencing and internal transcribed spacer (ITS) sequencing. Additionally, the change in colony count of bacterial and fungal colonies on the scalp before and after the treatment will be assessed using the Replicate Organism Detection and Counting (RODAC) method.
measure: Quality of Life change
time frame: 6 months
description: Quality of life will be calculated using the ScalpDex tool, a validated 23-item instrument that explains the way that patients with scalp dermatitis are affected by symptoms, functioning, and emotions.The scale is the Scalpdex quality of life instrument and asks questions about everyday activities such as wearing black clothes to itching. For the scale,the higher the score, the worse the outcome for the patient.
arm group label: Adults
arm group type: Experimental
description: All adults in the study will receive the treatment for dry scalp.
arm group label: Children
arm group type: Experimental
description: All children in the study will receive the treatment for dry scalp.
intervention type: Drug
intervention name: Natural Treatment
description: The participant will be given the treatment, which contains all natural ingredients, and a kit of all necessary materials to take home with them, which will include a set of instructions. The kit will contain the instruction handout and their treatment. They will be instructed to apply the treatment to their scalp, wait seven minutes, and then rinse their scalp. They will perform this entire procedure once per day for 14 days.
arm group label: Adults
arm group label: Children
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lucy Bilaver, PHD
role: Principal Investigator
affiliation: Feinberg School of Medicine- Northwestern
last name: Jennifer R Long
phone: 6306641231
email: jennifer.long@northwestern.edu
last name: Ruchi Gupta, MD, MPH
phone: 3125233533
email: r-gupta@northwestern.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Dermatitis, Seborrheic
sharing ipd: Undecided