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Completed

NCT Number: NCT06097494

Investigating Healthcare Disparities in Vitiligo

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.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Momentum Data Limited

London, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

Observational analysis of usual care only.

Primary outcomes

  1. Risk of Depression Within Patients With Vitiligo

    Time frame: 2 years

    Adjusted odds ratio calculated using logistic regression.

  2. Risk of Anxiety Within Patients With Vitiligo

    Time frame: 2 years

    Adjusted odds ratio calculated using logistic regression.

  3. Risk of Depression or Anxiety Within Patients With Vitiligo

    Time frame: 2 years

    Adjusted odds ratio of depression or anxiety in people with vitiligo calculated using logistic regression .

Secondary outcomes

  1. Primary Care Encounters

    Time frame: 2 years

    Describe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios

  2. Dermatology Referrals

    Time frame: 2 years

    Percentage of participants diagnosed with vitligo and having a recorded dermatology referral event wthin two year estimated using using the Kaplan-Meier method.

  3. Mental Health Referrals

    Time frame: 2 years

    Describe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios

  4. Unemployment

    Time frame: 2 years

    Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios.

  5. Time Off Work

    Time frame: 2 years

    Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios.

  6. Sleep Disturbance

    Time frame: 2 years

    Describe any disparities in sleep disturbance reported as adjusted hazard ratios.

Sponsors and collaborators

Lead sponsor

Momentum Data

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Healthcare Disparities in Vitiligo: a Population-based Cohort Study in the UK

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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