Investigating Healthcare Disparities in Vitiligo

NCT ID: NCT06097494

Last Updated: 2025-03-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39374 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-07-17

Brief Summary

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Vitiligo is an acquired, non contagious skin disorder characterised by depigmented patches of skin that may appear in a localised or very generalised distribution, and affecting 0.5-2.0% of the global population.There are however, limited population-based studies on the burden of vitiligo and disparities across people of different ethnicities and deprivation.

The overall purpose of this study is to provide an estimate of the lifetime risk of vitiligo in the population overall and by sociodemographic subgroups. Moreover, to do a subgroup analysis in the vitiligo population to identify health-related disparities across people in different sex, age, deprivation and ethnicity. A detailed understanding of the burden of disease in different sociodemographic groups is vital to plan resource provision.

Detailed Description

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This study will provide estimate of the cumulative lifetime risk of vitiligo in the population overall, and by important sociodemographic groups, including age, sex, ethnicity and deprivation, which will prevalent key data to show the relative burden of vitiligo across the aforementioned groups. These approaches allow creation of cumulative lifetime risk plots which provide an excellent and accessible way to display the relative disease burden across groups.

The cumulative lifetime risk of vitiligo will be estimated at age 80 years (approximate lifetime expectancy in the UK) using survival models, with age as the timescale and accounting for competing risk of death.

This study will also perform a subgroup analysis in the vitiligo population to identify health-related disparities across people in different deprivation, sex and ethnic groups. The disparities that will be considered are: Mental health conditions; healthcare utilisation; and work impact (time off work and unemployment),

The assessment of any associations with baseline characteristics and the outcome of interest will be used using Cox proportional hazards models (time to event outcomes) and generalised linear models.

Conditions

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Vitiligo

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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People with Vitiligo

Children and adults with new onset Vitiligo registered with OPCRD during the study period.

No intervention

Intervention Type OTHER

Observational analysis of usual care only.

People without Vitiligo

Children and adults without Vitiligo registered with OPCRD during the study period

No intervention

Intervention Type OTHER

Observational analysis of usual care only.

Interventions

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No intervention

Observational analysis of usual care only.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The cohort for the endpoint analysis will consist of all adults and adolescents (aged 13+) contributing to OPCRD during the study period (2004-2020).
* The cohort for the lifetime risk analysis will consist of all people contributing to OPCRD during the study period.
* The vitiligo cohort consists of people newly diagnosed with vitiligo at any point during the study period.

Exclusion Criteria

* People with the alternative non-vitiligo diagnoses (other hypopigmenting conditions).
* People with vitiligo diagnosis within 6 months of practice registration.
* People without vitiligo with less than 1 year of follow up within the dataset.
* People over the age of 95 (for those reaching age 95 during the follow up period follow up was censored at age 95).
* People who have opted out of record sharing.
Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Momentum Data

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew McGovern, MD

Role: STUDY_DIRECTOR

Momentum Data

Locations

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Momentum Data Limited

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Eleftheriadou V, Ahmed A, Nesnas J, Nagra R. The lifetime risk and impact of vitiligo across sociodemographic groups: a UK population-based cohort study. Br J Dermatol. 2024 Dec 23;192(1):63-71. doi: 10.1093/bjd/ljae282.

Reference Type DERIVED
PMID: 39018020 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P084

Identifier Type: -

Identifier Source: org_study_id

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