Alopecia AreataNCT05727306
Healthcare Disparities in Alopecia Areata
An observational study of Alopecia Areata, run by Momentum Data at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 95 years
- Conditions the study is for
- Alopecia Areata
- How many people
- 4,052,231 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 6 Aug 2024
- 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 12 to 95 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Patients aged greater than 12 over the study period.
- Registered with the contributing primary care practice for any duration during the study period
Who cannot join
- People diagnosed with AA before the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthcare Disparities in Alopecia Areata: UK Population-based Cohort Study
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.
Read the detailed description
The overall purpose of the study is to provide an estimate of the cumulative lifetime incidence of AA in the population overall and by important sociodemographic groups. Moreover, to do a subgroup analysis in the AA population to identify health-related disparities across people in different socioeconomic strata, geographical distribution, sex and ethnic groups. The disparities that will be considered are AA associated: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment).
The cumulative lifetime risk of AA was estimated at age 80 years (approximate life expectancy in the UK) using survival models, with age as the timescale and accounting for the competing risk of death.
The assessment of any associations with baseline characteristics and the outcomes of interest will be assessed using Cox proportional hazards models (time to event outcomes) and Poisson regression (repeated event outcomes) models.
- Conditions
- Alopecia Areata
- Being tested
- No intervention
- Medical subject headings
- Alopecia Areata
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 |
|---|---|---|
| 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. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likelihood of Depressive Episodes
Estimated using logistic regression and reported using adjusted odds ratios
Measured: 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
Measured: 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
Measured: 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
Estimated using negative binomial regression and reported as adjusted incidence rate ratio
Measured: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Relative Incidence of Dermatology Referrals
Estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio
Measured: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Relative Incidence Psychological Therapy
Estimated using Cox proportional hazard regression and reported as adjusted hazard ratio
Measured: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Relative Incidence of Unemployment
Unemployment identified by issue of IB113 or ESA113 forms for unemployment. Relative incidence estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio
Measured: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Relative Incidence of Time Off Work
Time off work identified by recorded issue of Med 3 certificate in primary care. Relative incidence estimated using Cox proportional hazard regression and reported as Adjusted hazard ratio
Measured: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Oct 2022
- Primary completion24 Jul 2024
- Study completion6 Aug 2024
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.
- Other trials for Alopecia AreataStudies 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
- 4,052,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Study director, Momentum Data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727306
- Sponsor's protocol ID
- p068
- Status last verified
- May 2025
- First submitted
- 11 Jan 2023
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Disparities in Alopecia Areata: UK Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT05727306
- Acronym / sponsor ID
- p068
- Conditions
- Alopecia Areata
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,052,231 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer, University of Oxford
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The overall purpose of the study is to provide an estimate of the cumulative lifetime incidence of AA in the population overall and by important sociodemographic groups. Moreover, to do a subgroup analysis in the AA population to identify health-related disparities across people in different socioeconomic strata, geographical distribution, sex and ethnic groups. The disparities that will be considered are AA associated: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment).
The cumulative lifetime risk of AA was estimated at age 80 years (approximate life expectancy in the UK) using survival models, with age as the timescale and accounting for the competing risk of death.
The assessment of any associations with baseline characteristics and the outcomes of interest will be assessed using Cox proportional hazards models (time to event outcomes) and Poisson regression (repeated event outcomes) models.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with Alopecia Areata | – | Other: No interventionChildren and adults aged 12+ with new onset Alopecia Areata registered with a contributing General practitioner (GP) practice during the study period. |
| People without Alopecia Areata | – | Other: No interventionChildren and adults aged 12+ without Alopecia Areata registered with a contributing GP practice during the study period. |
Who may qualify
- Ages
- 12 to 95 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients aged greater than 12 over the study period.
- Registered with the contributing primary care practice for any duration during the study period
Key exclusion criteria (1 listed)
- People diagnosed with AA before the study period.
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 | People with Alopecia Areata, People without Alopecia Areata |
Primary outcome
Likelihood of Depressive Episodes
Time frame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
Estimated using logistic regression and reported using adjusted odds ratios
Likelihood of Recurrent Major Depressive Disorder
Time frame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
Estimated using logistic regression and reported using adjusted odds ratios
Likelihood of Anxiety Disorder
Time frame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant
Estimated using logistic regression and reported using adjusted odds ratios
5 secondary outcomes
Relative Incidence of Primary Care Attendances
Time frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Relative Incidence of Dermatology Referrals
Time frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Relative Incidence Psychological Therapy
Time frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Relative Incidence of Unemployment
Time frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Relative Incidence of Time Off Work
Time frame: Data was collected retrospectively, assessed up to two years following initial Alopecia Areata diagnosis for each participant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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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
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 Alopecia Areata, 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 2 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 18 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 18 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?
Likelihood of Depressive Episodes (time frame: Data was collected retrospectively, assessed prior to and up to two years following initial Alopecia Areata diagnosis for each participant). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2025.