Clinical trial NCT03823794: Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)
Official title: The Epidemiology of Atopic Dermatitis, Associated Comorbidities, and Treatment Patterns in the United Kingdom (UK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis Eczema
Atopic Dermatitis
Eczema
Lead sponsor: Momentum Data
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
name: Oxford Royal College of General Practitioners Research and Surveillance Centre
First posted: 2019-01-30
Enrollment: 148166
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and children with atopic dermatitis identified from routinely collected healthcare records using a validated algorithm.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Mild Topical Corticosteroids (TCS)
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Moderate Topical Corticosteroids (TCS)
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Potent Topical Corticosteroids (TCS)
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Very Potent Topical Corticosteroids (TCS)
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Topical Calcineurin Inhibitors (TCI)
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Topical Antimicrobials
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Systemic Immuno-modulatory Therapy
timeFrame: Jan - Dec 2018 inclusive
measure: Prescription Rates for Atopic Dermatitis Related Treatments: Oral Corticosteroids
timeFrame: Jan - Dec 2018 inclusive
measure: Specialist Referrals
timeFrame: Jan - Dec 2018 inclusive
measure: Primary Care Referrals
timeFrame: Jan - Dec 2018 inclusive
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Momentum Data Ltd
Study officials:
affiliation: Momentum Data Ltd
name: Andrew McGovern, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.