NCT03823794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148,166

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2020

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

January 17, 2019

Results QC Date

January 30, 2023

Last Update Submit

May 19, 2025

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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.

    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)

    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)

    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)

    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)

    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)

    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.

    Jan - Dec 2018 inclusive

  • Prescription Rates for Atopic Dermatitis Related Treatments: Antihistamin

    Proportion of the arm/group receiving at least one prescription for antihistamin.

    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

    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

    Jan - Dec 2018 inclusive

  • Specialist Referrals

    Specialist dermatology referral rate in 2018

    Jan - Dec 2018 inclusive

  • Primary Care Referrals

    Annual rate of primary care consultations in 2018

    Jan - Dec 2018 inclusive

Study Arms (1)

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.

Other: No intervention

Interventions

Observational analysis of usual care only

Active atopic dermatitis

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults and children with atopic dermatitis identified from routinely collected healthcare records using a validated algorithm.

You may qualify if:

  • 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.

You may not qualify if:

  • The presence of psoriasis, photodermatitis, or ichthyosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Carsten Flohr
Organization
Guy's & St Thomas' NHS Foundation Trust

Study Officials

  • Andrew McGovern, MD

    Momentum Data Ltd

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 30, 2019

Study Start

February 1, 2019

Primary Completion

November 4, 2020

Study Completion

November 4, 2020

Last Updated

June 6, 2025

Results First Posted

June 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
There is no pre-specified time-frame for data availability; this will be considered on an individual basis for each request.
Access Criteria
As above

Locations