Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-07 @ 2:14 AM
Study NCT ID:
NCT03823794
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D004485', 'term': 'Eczema'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carsten.flohr@kcl.ac.uk', 'phone': '020 7188 8884', 'title': 'Carsten Flohr', 'organization': "Guy's & St Thomas' NHS Foundation Trust"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Death, serious adverse events, and other (non-serious adverse events) were not assessed for the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '76095', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for emollients and soap substitutes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Mild Topical Corticosteroids (TCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '40478', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for mild topical corticosteroids (atopic dermatitis related treatment)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Moderate Topical Corticosteroids (TCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '19575', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for moderate topical corticosteroids (an atopic dermatitis related treatment)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Potent Topical Corticosteroids (TCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '34997', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for potent topical corticosteroids (an atopic dermatitis related treatment)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Very Potent Topical Corticosteroids (TCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '6478', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for very potent topical corticosteroid (an atopic dermatitis related treatment)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Topical Calcineurin Inhibitors (TCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '2683', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for a topical Calcineurin Inhibitor (an atopic dermatitis related treatment)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Topical Antimicrobials', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '19378', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for topical antimicrobials.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '29041', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for antihistamin.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Systemic Immuno-modulatory Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '2785', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for Systemic immuno-modulatory therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Prescription Rates for Atopic Dermatitis Related Treatments: Oral Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '12087', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for oral corticosteroids', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Specialist Referrals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '5.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Specialist dermatology referral rate in 2018', 'unitOfMeasure': 'Referrals per 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Primary Care Referrals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'classes': [{'categories': [{'measurements': [{'value': '112.0', 'groupId': 'OG000', 'lowerLimit': '111.5', 'upperLimit': '112.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Annual rate of primary care consultations in 2018', 'unitOfMeasure': 'Consultations per 100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis (AD) during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148166', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Atopic Dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018. Primary outcomes conducted within this single arm.\n\nNo intervention: Observational analysis of usual care only'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age Group', 'categories': [{'title': '<2', 'measurements': [{'value': '7230', 'groupId': 'BG000'}]}, {'title': '2-11', 'measurements': [{'value': '34074', 'groupId': 'BG000'}]}, {'title': '12-17', 'measurements': [{'value': '12476', 'groupId': 'BG000'}]}, {'title': '18-49', 'measurements': [{'value': '37995', 'groupId': 'BG000'}]}, {'title': '>=50', 'measurements': [{'value': '56391', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '81357', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '66809', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '87717', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '14980', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '5799', 'groupId': 'BG000'}]}, {'title': 'Mixed', 'measurements': [{'value': '2808', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1234', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '35628', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IMD quintile', 'classes': [{'categories': [{'title': '1 (most deprived)', 'measurements': [{'value': '26454', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '25520', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '26445', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '31426', 'groupId': 'BG000'}]}, {'title': '5 (least deprived)', 'measurements': [{'value': '36467', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1854', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Index of Multiple Deprivation (IMD) is a UK national deprivation measure of deprivation which is based on the patient postcode. IMD has been stratified into quintiles with IMD 1 representing most deprived and IMD 5 being the least deprived.', 'unitOfMeasure': 'Participants'}, {'title': 'Rural-urban classification', 'classes': [{'categories': [{'title': 'Urban', 'measurements': [{'value': '117466', 'groupId': 'BG000'}]}, {'title': 'Rural', 'measurements': [{'value': '29005', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1695', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-21', 'size': 225634, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-17T05:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148166}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2019-01-17', 'resultsFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-19', 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for emollients and soap substitutes.'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Mild Topical Corticosteroids (TCS)', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for mild topical corticosteroids (atopic dermatitis related treatment)'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Moderate Topical Corticosteroids (TCS)', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for moderate topical corticosteroids (an atopic dermatitis related treatment)'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Potent Topical Corticosteroids (TCS)', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for potent topical corticosteroids (an atopic dermatitis related treatment)'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Very Potent Topical Corticosteroids (TCS)', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for very potent topical corticosteroid (an atopic dermatitis related treatment)'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Topical Calcineurin Inhibitors (TCI)', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for a topical Calcineurin Inhibitor (an atopic dermatitis related treatment)'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Topical Antimicrobials', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for topical antimicrobials.'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for antihistamin.'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Systemic Immuno-modulatory Therapy', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for Systemic immuno-modulatory therapy'}, {'measure': 'Prescription Rates for Atopic Dermatitis Related Treatments: Oral Corticosteroids', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Proportion of the arm/group receiving at least one prescription for oral corticosteroids'}, {'measure': 'Specialist Referrals', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Specialist dermatology referral rate in 2018'}, {'measure': 'Primary Care Referrals', 'timeFrame': 'Jan - Dec 2018 inclusive', 'description': 'Annual rate of primary care consultations in 2018'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis Eczema', 'Atopic Dermatitis', 'Eczema']}, 'referencesModule': {'references': [{'pmid': '33179341', 'type': 'DERIVED', 'citation': 'de Lusignan S, Alexander H, Broderick C, Dennis J, McGovern A, Feeney C, Flohr C. The epidemiology of eczema in children and adults in England: A population-based study using primary care data. Clin Exp Allergy. 2021 Mar;51(3):471-482. doi: 10.1111/cea.13784. Epub 2020 Nov 26.'}, {'pmid': '33176023', 'type': 'DERIVED', 'citation': 'de Lusignan S, Alexander H, Broderick C, Dennis J, McGovern A, Feeney C, Flohr C. Patterns and trends in eczema management in UK primary care (2009-2018): A population-based cohort study. Clin Exp Allergy. 2021 Mar;51(3):483-494. doi: 10.1111/cea.13783. Epub 2020 Nov 23.'}, {'pmid': '32938595', 'type': 'DERIVED', 'citation': 'de Lusignan S, Alexander H, Broderick C, Dennis J, McGovern A, Feeney C, Flohr C. Epidemiology and management of atopic dermatitis in England: an observational cohort study protocol. BMJ Open. 2020 Sep 16;10(9):e037518. doi: 10.1136/bmjopen-2020-037518.'}]}, 'descriptionModule': {'briefSummary': 'Atopic dermatitis (AD), 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.\n\nMost 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.', 'detailedDescription': 'Objective\n\nThe study aims to describe the health care resource utilisation of patients with active AD in terms of prescription use, primary care appointments, and specialist referrals.\n\nMethod 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 a cohort of prevalent active AD cases over a one year period (2018). The annual use of topical and oral medications used for the treatment of AD, primary care appointments, and specialist referrals will be reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults and children with atopic dermatitis identified from routinely collected healthcare records using a validated algorithm.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All paediatric and adult patients registered with an Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) contributing GP practice during the study period (2008-2018) and with at least one year of follow-up.\n\nExclusion Criteria:\n\n* The presence of psoriasis, photodermatitis, or ichthyosis'}, 'identificationModule': {'nctId': 'NCT03823794', 'briefTitle': 'Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Momentum Data'}, 'officialTitle': 'The Epidemiology of Atopic Dermatitis, Associated Comorbidities, and Treatment Patterns in the United Kingdom (UK)', 'orgStudyIdInfo': {'id': 'P002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active atopic dermatitis', 'description': 'People fulfilling the diagnostic criteria for active atopic dermatitis during the calendar year 2018, and meeting the inclusion criteria and registered with one of the study practices for one or more years during the study period.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Observational analysis of usual care only', 'armGroupLabels': ['Active atopic dermatitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1X 8QT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Momentum Data Ltd', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Andrew McGovern, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Momentum Data Ltd'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'As above'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Momentum Data', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Oxford Royal College of General Practitioners Research and Surveillance Centre', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}