<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/NCT04404075</url>
  </required_header>
  <id_info>
    <org_study_id>19-28676</org_study_id>
    <nct_id>NCT04404075</nct_id>
  </id_info>
  <brief_title>Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use</brief_title>
  <official_title>Skin Tracker: A Mobile Health App to Monitor Skin Disease Activity and Treatment Use</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>
      Design and beta-test a research-oriented mobile health app to assess disease activity,&#xD;
      quality of life, treatment patterns, adverse medication effects, and lifestyle factors in&#xD;
      patients with atopic dermatitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mobile health technology, including smartphone apps and wearable monitors, has tremendous&#xD;
      potential to transform clinical research. Recording of patient outcomes on a smartphone&#xD;
      device and camera in the home setting can greatly reduce the number of in person research&#xD;
      visits, saving tremendous costs, time, and effort associated with data entry. This also&#xD;
      allows for easier recruitment of study subjects, who can be enrolled in geographic locations&#xD;
      beyond academic research centers. After FDA approval of a therapy, mobile health technology&#xD;
      can help researchers understand how that particular therapy is being used in a real-world&#xD;
      setting, including frequency of use, adverse events, and impact of use on disease symptoms&#xD;
      and patient quality of life. In this study, the investigators will create a mobile app to&#xD;
      help the atopic dermatitis community understand the types of data and quality of data that&#xD;
      can be gathered from atopic dermatitis patients longitudinally. A review of existing atopic&#xD;
      dermatitis mobile apps on the market reveals they are consumer-oriented and may not be able&#xD;
      to fully capture high-quality research data. The investigator proposed app is specifically&#xD;
      geared for research, and thus fills an important gap. The research team will develop&#xD;
      SkinTracker, a research-oriented eczema app to longitudinally track atopic dermatitis&#xD;
      severity, symptoms, quality of life, physical activity, medication usage, and adverse events&#xD;
      in a real-world setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 25, 2022</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Average change in eczema area and severity index EASI score at month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Patient eczema area and severity index (EASI) will be measured. It is a tool for measuring the amount and severity of eczema a patient has on his or her body, scale is 0-72, 0 means clear and 72 means severe eczema</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average change in eczema area and severity index EASI score at month 3</measure>
    <time_frame>Month 3</time_frame>
    <description>Patient eczema area and severity index (EASI) will be measured. It is a tool for measuring the amount and severity of eczema a patient has on his or her body, scale is 0-72, 0 means clear and 72 means severe eczema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average change in Investigator global assessment (IGA) at month 6</measure>
    <time_frame>Month 6</time_frame>
    <description>Patient Investigator global assessment (IGA) score will be measured from 12 to 18 months, it is a scale to estimate overall severity of eczema but does not take into account BSA specifically, scale is 0 to 4, 0 is clear and 4 is severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average change in Investigator global assessment (IGA) at month 3</measure>
    <time_frame>Month 3</time_frame>
    <description>Patient Investigator global assessment (IGA) score will be measured from 12 to 18 months, it is a scale to estimate overall severity of eczema but does not take into account BSA specifically, scale is 0 to 4, 0 is clear and 4 is severe</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Atopic Dermatitis</condition>
  <condition>Eczema</condition>
  <arm_group>
    <arm_group_label>Group 1 patients</arm_group_label>
    <description>Age 18 and above&#xD;
Eczema Area and Severity Index (EASI) score ≥ 10&#xD;
Investigator Global Assessment (IGA) ≥ 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 patients</arm_group_label>
    <description>Age 18 and above&#xD;
Eczema Area and Severity Index (EASI) score ≥ 1 but &lt; 10&#xD;
Investigator Global Assessment (IGA) 1 or 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 patients</arm_group_label>
    <description>Age 12 to 17&#xD;
Eczema Area and Severity Index (EASI) score ≥ 10&#xD;
Investigator Global Assessment (IGA) ≥ 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4 patients</arm_group_label>
    <description>Age 12 to 17&#xD;
Eczema Area and Severity Index (EASI) score ≥ 1 but &lt; 10&#xD;
Investigator Global Assessment (IGA) 1 or 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SkinTracker Mobile App</intervention_name>
    <description>a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting</description>
    <arm_group_label>Group 1 patients</arm_group_label>
    <arm_group_label>Group 2 patients</arm_group_label>
    <arm_group_label>Group 3 patients</arm_group_label>
    <arm_group_label>Group 4 patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This is a single-center, observational, pilot study. Ten subjects with atopic dermatitis&#xD;
        will be enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to provide written informed consent and comply with the protocol.&#xD;
&#xD;
          2. At least 13 years of age.&#xD;
&#xD;
          3. Diagnosis of atopic dermatitis by dermatologist for at least 6 months.&#xD;
&#xD;
          4. Physical exam within clinically acceptable limits.&#xD;
&#xD;
          5. Own or have access to a mobile device that is compatible with study mobile application&#xD;
             SkinTracker.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is unable to provide written informed consent or comply with the protocol.&#xD;
&#xD;
          2. Unable to input data into SkinTracker mobile app.&#xD;
&#xD;
          3. Subject is younger than 13 years of age.&#xD;
&#xD;
          4. Serious known infection.&#xD;
&#xD;
          5. History of immunosuppression (including human immunodeficiency virus (HIV)).&#xD;
&#xD;
          6. History of malignancy within 5 years prior to screening visit, except completely&#xD;
             treated in situ carcinoma of the cervix, completely treated and resolved&#xD;
             non-metastatic squamous or basal cell carcinoma of the skin.&#xD;
&#xD;
          7. Severe concomitant illness.&#xD;
&#xD;
          8. Physical exam not within clinically acceptable limits.&#xD;
&#xD;
          9. Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her&#xD;
             from safely participating in this study or interfere&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Wilson Liao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF Psoriasis and Skin Treatment Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mimi Chung</last_name>
      <phone>415-944-7618</phone>
      <email>mimi.chung@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Wilson Liao, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</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>Skin Diseases</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/NCT04404075
org study id: 19-28676
nct id: NCT04404075
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Design and beta-test a research-oriented mobile health app to assess disease activity,
      quality of life, treatment patterns, adverse medication effects, and lifestyle factors in
      patients with atopic dermatitis.
Mobile health technology, including smartphone apps and wearable monitors, has tremendous
      potential to transform clinical research. Recording of patient outcomes on a smartphone
      device and camera in the home setting can greatly reduce the number of in person research
      visits, saving tremendous costs, time, and effort associated with data entry. This also
      allows for easier recruitment of study subjects, who can be enrolled in geographic locations
      beyond academic research centers. After FDA approval of a therapy, mobile health technology
      can help researchers understand how that particular therapy is being used in a real-world
      setting, including frequency of use, adverse events, and impact of use on disease symptoms
      and patient quality of life. In this study, the investigators will create a mobile app to
      help the atopic dermatitis community understand the types of data and quality of data that
      can be gathered from atopic dermatitis patients longitudinally. A review of existing atopic
      dermatitis mobile apps on the market reveals they are consumer-oriented and may not be able
      to fully capture high-quality research data. The investigator proposed app is specifically
      geared for research, and thus fills an important gap. The research team will develop
      SkinTracker, a research-oriented eczema app to longitudinally track atopic dermatitis
      severity, symptoms, quality of life, physical activity, medication usage, and adverse events
      in a real-world setting.
observational model: Other
time perspective: Prospective
measure: Average change in eczema area and severity index EASI score at month 6
time frame: Month 6
description: Patient eczema area and severity index (EASI) will be measured. It is a tool for measuring the amount and severity of eczema a patient has on his or her body, scale is 0-72, 0 means clear and 72 means severe eczema
measure: Average change in eczema area and severity index EASI score at month 3
time frame: Month 3
description: Patient eczema area and severity index (EASI) will be measured. It is a tool for measuring the amount and severity of eczema a patient has on his or her body, scale is 0-72, 0 means clear and 72 means severe eczema
measure: Average change in Investigator global assessment (IGA) at month 6
time frame: Month 6
description: Patient Investigator global assessment (IGA) score will be measured from 12 to 18 months, it is a scale to estimate overall severity of eczema but does not take into account BSA specifically, scale is 0 to 4, 0 is clear and 4 is severe
measure: Average change in Investigator global assessment (IGA) at month 3
time frame: Month 3
description: Patient Investigator global assessment (IGA) score will be measured from 12 to 18 months, it is a scale to estimate overall severity of eczema but does not take into account BSA specifically, scale is 0 to 4, 0 is clear and 4 is severe
arm group label: Group 1 patients
description: Age 18 and above
Eczema Area and Severity Index (EASI) score ≥ 10
Investigator Global Assessment (IGA) ≥ 3
arm group label: Group 2 patients
description: Age 18 and above
Eczema Area and Severity Index (EASI) score ≥ 1 but < 10
Investigator Global Assessment (IGA) 1 or 2
arm group label: Group 3 patients
description: Age 12 to 17
Eczema Area and Severity Index (EASI) score ≥ 10
Investigator Global Assessment (IGA) ≥ 3
arm group label: Group 4 patients
description: Age 12 to 17
Eczema Area and Severity Index (EASI) score ≥ 1 but < 10
Investigator Global Assessment (IGA) 1 or 2
intervention type: Other
intervention name: SkinTracker Mobile App
description: a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting
arm group label: Group 1 patients
arm group label: Group 2 patients
arm group label: Group 3 patients
arm group label: Group 4 patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
last name: Wilson Liao, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Dermatitis
mesh term: Skin Diseases
sharing ipd: No