- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03823794
Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)
The Epidemiology of Atopic Dermatitis, Associated Comorbidities, and Treatment Patterns in the United Kingdom (UK)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective
The 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.
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 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, WC1X 8QT
- Momentum Data Ltd
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The presence of psoriasis, photodermatitis, or ichthyosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Active atopic dermatitis
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.
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Observational analysis of usual care only
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for emollients and soap substitutes.
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Jan - Dec 2018 inclusive
|
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Prescription Rates for Atopic Dermatitis Related Treatments: Mild Topical Corticosteroids (TCS)
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for mild topical corticosteroids (atopic dermatitis related treatment)
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Jan - Dec 2018 inclusive
|
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Prescription Rates for Atopic Dermatitis Related Treatments: Moderate Topical Corticosteroids (TCS)
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for moderate topical corticosteroids (an atopic dermatitis related treatment)
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Jan - Dec 2018 inclusive
|
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Prescription Rates for Atopic Dermatitis Related Treatments: Potent Topical Corticosteroids (TCS)
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for potent topical corticosteroids (an atopic dermatitis related treatment)
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Jan - Dec 2018 inclusive
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Prescription Rates for Atopic Dermatitis Related Treatments: Very Potent Topical Corticosteroids (TCS)
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for very potent topical corticosteroid (an atopic dermatitis related treatment)
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Jan - Dec 2018 inclusive
|
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Prescription Rates for Atopic Dermatitis Related Treatments: Topical Calcineurin Inhibitors (TCI)
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for a topical Calcineurin Inhibitor (an atopic dermatitis related treatment)
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Jan - Dec 2018 inclusive
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Prescription Rates for Atopic Dermatitis Related Treatments: Topical Antimicrobials
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for topical antimicrobials.
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Jan - Dec 2018 inclusive
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Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for antihistamin.
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Jan - Dec 2018 inclusive
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Prescription Rates for Atopic Dermatitis Related Treatments: Systemic Immuno-modulatory Therapy
Time Frame: Jan - Dec 2018 inclusive
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Proportion of the arm/group receiving at least one prescription for Systemic immuno-modulatory therapy
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Jan - Dec 2018 inclusive
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Prescription Rates for Atopic Dermatitis Related Treatments: Oral Corticosteroids
Time Frame: Jan - Dec 2018 inclusive
|
Proportion of the arm/group receiving at least one prescription for oral corticosteroids
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Jan - Dec 2018 inclusive
|
|
Specialist Referrals
Time Frame: Jan - Dec 2018 inclusive
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Specialist dermatology referral rate in 2018
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Jan - Dec 2018 inclusive
|
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Primary Care Referrals
Time Frame: Jan - Dec 2018 inclusive
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Annual rate of primary care consultations in 2018
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Jan - Dec 2018 inclusive
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Time to occurrence of moderate atopic dermatitis
Time Frame: Models will be devised using data from 2008-2018
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The impact of sociodemographic predictors on time to first occurrence of moderate atopic dermatitis
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Models will be devised using data from 2008-2018
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Time to occurrence of severe atopic dermatitis
Time Frame: Models will be devised using data from 2008-2018
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The impact of sociodemographic predictors on time to first occurrence of severe atopic dermatitis
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Models will be devised using data from 2008-2018
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Time to recurrence of active atopic dermatitis
Time Frame: Models will be devised using data from 2008-2018
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The impact of sociodemographic predictors on time to first recurrence of atopic dermatitis in those with inactive disease
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Models will be devised using data from 2008-2018
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Andrew McGovern, MD, Momentum Data Ltd
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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