Atopic Dermatitis EczemaNCT03823794
Trends in the Epidemiology and Treatment of Atopic Dermatitis in the United Kingdom (UK)
An observational study of Atopic Dermatitis Eczema and Atopic Dermatitis, run by Momentum Data at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis Eczema, Atopic Dermatitis, Eczema
- How many people
- 148,166 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 4 Nov 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults and children with atopic dermatitis identified from routinely collected healthcare records using a validated algorithm.
Who may be able to join
- 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.
Who cannot join
- The presence of psoriasis, photodermatitis, or ichthyosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Atopic Dermatitis Eczema, Atopic Dermatitis, Eczema
- Being tested
- No intervention
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational analysis of usual care only
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes
Proportion of the arm/group receiving at least one prescription for emollients and soap substitutes.
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Mild Topical Corticosteroids (TCS)
Proportion of the arm/group receiving at least one prescription for mild topical corticosteroids (atopic dermatitis related treatment)
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Moderate Topical Corticosteroids (TCS)
Proportion of the arm/group receiving at least one prescription for moderate topical corticosteroids (an atopic dermatitis related treatment)
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Potent Topical Corticosteroids (TCS)
Proportion of the arm/group receiving at least one prescription for potent topical corticosteroids (an atopic dermatitis related treatment)
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Very Potent Topical Corticosteroids (TCS)
Proportion of the arm/group receiving at least one prescription for very potent topical corticosteroid (an atopic dermatitis related treatment)
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Topical Calcineurin Inhibitors (TCI)
Proportion of the arm/group receiving at least one prescription for a topical Calcineurin Inhibitor (an atopic dermatitis related treatment)
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Topical Antimicrobials
Proportion of the arm/group receiving at least one prescription for topical antimicrobials.
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin
Proportion of the arm/group receiving at least one prescription for antihistamin.
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Systemic Immuno-modulatory Therapy
Proportion of the arm/group receiving at least one prescription for Systemic immuno-modulatory therapy
Measured: Jan - Dec 2018 inclusive
Prescription Rates for Atopic Dermatitis Related Treatments: Oral Corticosteroids
Proportion of the arm/group receiving at least one prescription for oral corticosteroids
Measured: Jan - Dec 2018 inclusive
Specialist Referrals
Specialist dermatology referral rate in 2018
Measured: Jan - Dec 2018 inclusive
Primary Care Referrals
Annual rate of primary care consultations in 2018
Measured: Jan - Dec 2018 inclusive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Feb 2019
- Primary completion4 Nov 2020
- Study completion4 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 148,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, Oxford Royal College of General Practitioners Research and Surveillance Centre
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Study director, Momentum Data Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823794
- Sponsor's protocol ID
- P002
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2019
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 33179341de 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.
PubMed 33176023de 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.
PubMed 32938595
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology of Atopic Dermatitis, Associated Comorbidities, and Treatment Patterns in the United Kingdom (UK)
- ClinicalTrials.gov ID
- NCT03823794
- Acronym / sponsor ID
- P002
- Conditions
- Atopic Dermatitis Eczema, Atopic Dermatitis, Eczema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148,166 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer, Oxford Royal College of General Practitioners Research and Surveillance Centre
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active atopic dermatitis | – | Other: No interventionPeople 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. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with atopic dermatitis identified from routinely collected healthcare records using a validated algorithm.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The presence of psoriasis, photodermatitis, or ichthyosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational analysis of usual care only | Other | Active atopic dermatitis |
Primary outcome
Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for emollients and soap substitutes.
Prescription Rates for Atopic Dermatitis Related Treatments: Mild Topical Corticosteroids (TCS)
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for mild topical corticosteroids (atopic dermatitis related treatment)
Prescription Rates for Atopic Dermatitis Related Treatments: Moderate Topical Corticosteroids (TCS)
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for moderate topical corticosteroids (an atopic dermatitis related treatment)
Prescription Rates for Atopic Dermatitis Related Treatments: Potent Topical Corticosteroids (TCS)
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for potent topical corticosteroids (an atopic dermatitis related treatment)
Prescription Rates for Atopic Dermatitis Related Treatments: Very Potent Topical Corticosteroids (TCS)
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for very potent topical corticosteroid (an atopic dermatitis related treatment)
Prescription Rates for Atopic Dermatitis Related Treatments: Topical Calcineurin Inhibitors (TCI)
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for a topical Calcineurin Inhibitor (an atopic dermatitis related treatment)
Prescription Rates for Atopic Dermatitis Related Treatments: Topical Antimicrobials
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for topical antimicrobials.
Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for antihistamin.
Prescription Rates for Atopic Dermatitis Related Treatments: Systemic Immuno-modulatory Therapy
Time frame: Jan - Dec 2018 inclusive
Proportion of the arm/group receiving at least one prescription for Systemic immuno-modulatory therapy
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
Specialist Referrals
Time frame: Jan - Dec 2018 inclusive
Specialist dermatology referral rate in 2018
Primary Care Referrals
Time frame: Jan - Dec 2018 inclusive
Annual rate of primary care consultations in 2018
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33179341de 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.
- Derived from this study: PubMed 33176023de 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.
- Derived from this study: PubMed 32938595de 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew McGovern, MD study director
Momentum Data Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis Eczema and Atopic Dermatitis, run by Momentum Data at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription Rates for Atopic Dermatitis Related Treatments: Emollients and Soap Substitutes (time frame: Jan - Dec 2018 inclusive). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823794, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.