NCT05727306

Brief Summary

Alopecia areata (AA) is a common immune-mediated non-scarring alopecia often associated with substantial morbidity. There are however, limited population-based data on potential disparities in the burden of AA, including across people of different ethnicities and deprivation. We aimed to provide the first large-scale, population-based estimate of lifetime risk of AA overall and by important sociodemographic subgroups. As AA is associated with an increased burden of mental health conditions and work-related outcomes (unemployment, time off work), a detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,052,231

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

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

Study Start

First participant enrolled

October 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

June 18, 2025

Completed
Last Updated

June 18, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

January 11, 2023

Results QC Date

January 27, 2025

Last Update Submit

May 30, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Likelihood of Depressive Episodes

    Estimated using logistic regression and reported using adjusted odds ratios

    Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant

  • Likelihood of Recurrent Major Depressive Disorder

    Estimated using logistic regression and reported using adjusted odds ratios

    Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant

  • Likelihood of Anxiety Disorder

    Estimated using logistic regression and reported using adjusted odds ratios

    Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant

Secondary Outcomes (5)

  • Relative Incidence of Primary Care Attendances

    Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant

  • Relative Incidence of Dermatology Referrals

    Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant

  • Relative Incidence Psychological Therapy

    Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant

  • Relative Incidence of Unemployment

    Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant

  • Relative Incidence of Time Off Work

    Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant

Study Arms (2)

People with Alopecia Areata

Children and adults aged 12+ with new onset Alopecia Areata registered with a contributing General practitioner (GP) practice during the study period.

Other: No intervention

People without Alopecia Areata

Children and adults aged 12+ without Alopecia Areata registered with a contributing GP practice during the study period.

Other: No intervention

Interventions

Observational analysis of usual care only.

People with Alopecia AreataPeople without Alopecia Areata

Eligibility Criteria

Age12 Years - 95 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All individuals with new onset AA during the study period defined by the presence of at least one disease specific diagnostic code will be eligible for inlcusion in the AA cohort. Controls will be matched people without AA matched on age, sex, geography, ethnicity, socioeconomic status.

You may qualify if:

  • Patients aged greater than 12 over the study period.
  • Registered with the contributing primary care practice for any duration during the study period

You may not qualify if:

  • People diagnosed with AA before the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Momentum Data Limited

London, United Kingdom

Location

MeSH Terms

Conditions

Alopecia Areata

Condition Hierarchy (Ancestors)

AlopeciaHypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Andrew G. Messenger
Organization
University of Sheffield

Study Officials

  • Andrew McGovern, MD

    Momentum Data

    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 11, 2023

First Posted

February 14, 2023

Study Start

October 1, 2022

Primary Completion

July 24, 2024

Study Completion

August 6, 2024

Last Updated

June 18, 2025

Results First Posted

June 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Individual patient data is confidential but can be made available in an anonymised form to bone fide researchers subject to the required data protection training and other requirements. All data will remain behind a firewall and will only be available for access through a secured computer network.

Shared Documents
SAP
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