<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/NCT03823794</url>
  </required_header>
  <id_info>
    <org_study_id>P002</org_study_id>
    <nct_id>NCT03823794</nct_id>
  </id_info>
  <brief_title>Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)</brief_title>
  <official_title>The Epidemiology of Atopic Dermatitis, Associated Comorbidities, and Treatment Patterns in the United Kingdom (UK)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Momentum Data</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal College of General Practitioners Research and Surveillance Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Momentum Data</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>
      Atopic dermatitis, commonly called eczema, is one of the most frequently occurring skin&#xD;
      conditions. It is estimated to affect around one fifth of children in developed countries and&#xD;
      is also becoming increasingly common in less developed countries. Exact estimates of how&#xD;
      common eczema is, vary considerably and there has not been an in-depth analysis of the number&#xD;
      of people with eczema in the UK. It is also unclear which groups of people are most affected&#xD;
      and which treatment options are being used.&#xD;
&#xD;
      Most people with eczema are managed by their general practitioner (GP) with only a few people&#xD;
      requiring specialist care. GP records therefore provide an excellent opportunity to explore&#xD;
      how common eczema is and which treatments are being used currently. This study aims to&#xD;
      provide accurate estimates of the number of people with current eczema (prevalence), number&#xD;
      developing new onset eczema (incidence), and the pattern of common comorbidities in people&#xD;
      with eczema. It also aims describe current treatment patterns by age groups and other&#xD;
      factors. It also will look back over the last decade to identify how the number of people&#xD;
      with eczema and treatments changing over time. The study will also explore patterns in the&#xD;
      people most commonly affected and in the treatments used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective&#xD;
&#xD;
      This study aims to calculate current and accurate prevalence and incidence estimates for&#xD;
      atopic dermatitis (AD) by age group and sociodemographic factors. It also aims to describe&#xD;
      the burden of comorbidity in AD with a focus on atopic and mental health conditions. The&#xD;
      study also aims to describe the health care resource utilisation of this cohort in terms of&#xD;
      prescription use, primary care appointments, and specialist referrals.&#xD;
&#xD;
      Method This study will define AD cases using a previously validated algorithm for case&#xD;
      identification use clinical codes form primary care in the UK (Read codes). The study will&#xD;
      analyse the population prevalence and incidence of AD using this definition over a 10-year&#xD;
      period (2008-2018). Within this population the prevalence of autoimmune conditions&#xD;
      (rheumatoid arthritis, inflammatory bowel disease, coeliac disease, type 1 diabetes, and&#xD;
      multiple sclerosis) will be reported and compared with a cohort of individuals without a&#xD;
      diagnosis of AD, matched by age and sex at GP practice level. In the same cohort, the annual&#xD;
      use of topical and oral medications used for the treatment of AD, primary care appointments,&#xD;
      and specialist referrals, overall and stratified by sociodemographic factors will also be&#xD;
      reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of atopic dermatitis</measure>
    <time_frame>Measure will be reported annually by year from 2008-2018</time_frame>
    <description>Incidence of atopic dermatitis reported by predefined sociodemographic factors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The prevalence of atopic dermatitis</measure>
    <time_frame>Measure will be reported annually by year from 2008-2018</time_frame>
    <description>Prevalence of atopic dermatitis reported by predefined sociodemographic factors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis</measure>
    <time_frame>Prevelence reported annually by year from 2008-2018</time_frame>
    <description>Co-morbidities to be reported comprise; asthma, allergic rhinitis (hay fever), depression, anxiety, attention deficit hyperactivity disorder (ADHD), cardiovascular diseases (CVD; comprising myocardial infarction, angina, heart failure, atrial fibrillation, and stroke), rheumatoid arthritis, inflammatory bowel disease (ulcerative colitis and Crohn's disease), type 1 and type 2 diabetes, multiple sclerosis (MS) and coeliac disease. The presence of these co-morbidities will be identified from existing primary care records.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis</measure>
    <time_frame>Measures will be reported annually by year from 2008-2018</time_frame>
    <description>Service utilisation events comprise; primary care visits related to atopic dermatitis (prescription of treatment or coding of AD related problem), specialist care referrals to dermatology, and emergency admissions to dermatology. These events will also be reported separately.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual prescription rates for atopic dermatitis related treatments</measure>
    <time_frame>Measures will be reported annually by year from 2008-2018</time_frame>
    <description>Treatment rates will be reported separately and comprise: emollients and soap substitutes, topical steroids, topical antimicrobial therapies, combination topical therapies, topical calcineurin inhibitors, and oral immune modulating treatments, and phototherapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to occurrence of moderate atopic dermatitis</measure>
    <time_frame>Models will be devised using data from 2008-2018</time_frame>
    <description>The impact of sociodemographic predictors on time to first occurrence of moderate atopic dermatitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to occurrence of severe atopic dermatitis</measure>
    <time_frame>Models will be devised using data from 2008-2018</time_frame>
    <description>The impact of sociodemographic predictors on time to first occurrence of severe atopic dermatitis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence of active atopic dermatitis</measure>
    <time_frame>Models will be devised using data from 2008-2018</time_frame>
    <description>The impact of sociodemographic predictors on time to first recurrence of atopic dermatitis in those with inactive disease</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">411931</enrollment>
  <condition>Atopic Dermatitis Eczema</condition>
  <condition>Atopic Dermatitis</condition>
  <condition>Eczema</condition>
  <arm_group>
    <arm_group_label>Prevalent case of atopic dermatitis</arm_group_label>
    <description>People with atopic dermatitis meeting the inclusion criteria and registered with one of the study practices for one or more years during the study period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Age, gender and primary care practice-matched controls without a diagnosis of atopic dermatitis or another exclusion condition (psoriasis, photodermatitis, or ichthyosis) and registered with one of the study practices for one or more years during the study period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Observational analysis of usual care only</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Prevalent case of atopic dermatitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults and children with atopic dermatitis identified from routinely collected healthcare&#xD;
        records using a validated algorithm.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All paediatric and adult patients registered with an Royal College of General&#xD;
             Practitioners (RCGP) Research and Surveillance Centre (RSC) contributing GP practice&#xD;
             during the study period (2008-2018) and with at least one year of follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of psoriasis, photodermatitis, or ichthyosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Momentum Data Ltd</name>
      <address>
        <city>London</city>
        <zip>WC1X 8QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All individual patient data (IPD) can be made available to bone fide researchers subject to appropriate checks and approvals made by Momentum Data, the RCGP RSC, and the University of Surrey and subject to the completion of information governance training.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.</ipd_time_frame>
    <ipd_access_criteria>As above</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03823794/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>January 30, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03823794
org study id: P002
nct id: NCT03823794
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Atopic dermatitis, commonly called eczema, is one of the most frequently occurring skin
      conditions. It is estimated to affect around one fifth of children in developed countries and
      is also becoming increasingly common in less developed countries. Exact estimates of how
      common eczema is, vary considerably and there has not been an in-depth analysis of the number
      of people with eczema in the UK. It is also unclear which groups of people are most affected
      and which treatment options are being used.

      Most people with eczema are managed by their general practitioner (GP) with only a few people
      requiring specialist care. GP records therefore provide an excellent opportunity to explore
      how common eczema is and which treatments are being used currently. This study aims to
      provide accurate estimates of the number of people with current eczema (prevalence), number
      developing new onset eczema (incidence), and the pattern of common comorbidities in people
      with eczema. It also aims describe current treatment patterns by age groups and other
      factors. It also will look back over the last decade to identify how the number of people
      with eczema and treatments changing over time. The study will also explore patterns in the
      people most commonly affected and in the treatments used.
Objective

      This study aims to calculate current and accurate prevalence and incidence estimates for
      atopic dermatitis (AD) by age group and sociodemographic factors. It also aims to describe
      the burden of comorbidity in AD with a focus on atopic and mental health conditions. The
      study also aims to describe the health care resource utilisation of this cohort in terms of
      prescription use, primary care appointments, and specialist referrals.

      Method This study will define AD cases using a previously validated algorithm for case
      identification use clinical codes form primary care in the UK (Read codes). The study will
      analyse the population prevalence and incidence of AD using this definition over a 10-year
      period (2008-2018). Within this population the prevalence of autoimmune conditions
      (rheumatoid arthritis, inflammatory bowel disease, coeliac disease, type 1 diabetes, and
      multiple sclerosis) will be reported and compared with a cohort of individuals without a
      diagnosis of AD, matched by age and sex at GP practice level. In the same cohort, the annual
      use of topical and oral medications used for the treatment of AD, primary care appointments,
      and specialist referrals, overall and stratified by sociodemographic factors will also be
      reported.
observational model: Cohort
time perspective: Retrospective
measure: The incidence of atopic dermatitis
time frame: Measure will be reported annually by year from 2008-2018
description: Incidence of atopic dermatitis reported by predefined sociodemographic factors
measure: The prevalence of atopic dermatitis
time frame: Measure will be reported annually by year from 2008-2018
description: Prevalence of atopic dermatitis reported by predefined sociodemographic factors
measure: The prevalence of diagnosed co-morbidities in people with and without atopic dermatitis
time frame: Prevelence reported annually by year from 2008-2018
description: Co-morbidities to be reported comprise; asthma, allergic rhinitis (hay fever), depression, anxiety, attention deficit hyperactivity disorder (ADHD), cardiovascular diseases (CVD; comprising myocardial infarction, angina, heart failure, atrial fibrillation, and stroke), rheumatoid arthritis, inflammatory bowel disease (ulcerative colitis and Crohn's disease), type 1 and type 2 diabetes, multiple sclerosis (MS) and coeliac disease. The presence of these co-morbidities will be identified from existing primary care records.
measure: Annual rates of service utilisation (number of primary and secondary care visits) in people with atopic dermatitis
time frame: Measures will be reported annually by year from 2008-2018
description: Service utilisation events comprise; primary care visits related to atopic dermatitis (prescription of treatment or coding of AD related problem), specialist care referrals to dermatology, and emergency admissions to dermatology. These events will also be reported separately.
measure: Annual prescription rates for atopic dermatitis related treatments
time frame: Measures will be reported annually by year from 2008-2018
description: Treatment rates will be reported separately and comprise: emollients and soap substitutes, topical steroids, topical antimicrobial therapies, combination topical therapies, topical calcineurin inhibitors, and oral immune modulating treatments, and phototherapy.
measure: Time to occurrence of moderate atopic dermatitis
time frame: Models will be devised using data from 2008-2018
description: The impact of sociodemographic predictors on time to first occurrence of moderate atopic dermatitis
measure: Time to occurrence of severe atopic dermatitis
time frame: Models will be devised using data from 2008-2018
description: The impact of sociodemographic predictors on time to first occurrence of severe atopic dermatitis
measure: Time to recurrence of active atopic dermatitis
time frame: Models will be devised using data from 2008-2018
description: The impact of sociodemographic predictors on time to first recurrence of atopic dermatitis in those with inactive disease
arm group label: Prevalent case of atopic dermatitis
description: People with atopic dermatitis meeting the inclusion criteria and registered with one of the study practices for one or more years during the study period.
arm group label: Controls
description: Age, gender and primary care practice-matched controls without a diagnosis of atopic dermatitis or another exclusion condition (psoriasis, photodermatitis, or ichthyosis) and registered with one of the study practices for one or more years during the study period.
intervention type: Other
intervention name: No intervention
description: Observational analysis of usual care only
arm group label: Controls
arm group label: Prevalent case of atopic dermatitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: Yes
ipd description: All individual patient data (IPD) can be made available to bone fide researchers subject to appropriate checks and approvals made by Momentum Data, the RCGP RSC, and the University of Surrey and subject to the completion of information governance training.
ipd info type: Study Protocol
ipd time frame: There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
ipd access criteria: As above
provided document: 
submitted: January 30, 2023