Investigating Healthcare Disparities in Vitiligo

NCT06097494 | Completed Results

• 1 other identifier: P084
• Study Type: observational
• Target: 39,374
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (3)

• Risk of Depression Within Patients With Vitiligo

  Adjusted odds ratio calculated using logistic regression.

  2 years

• Risk of Anxiety Within Patients With Vitiligo

  Adjusted odds ratio calculated using logistic regression.

  2 years

• Risk of Depression or Anxiety Within Patients With Vitiligo

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

  2 years

Secondary Outcomes (6)

• Primary Care Encounters

  2 years

• Dermatology Referrals

  2 years

• Mental Health Referrals

  2 years

• Unemployment

  2 years

• Time Off Work

  2 years

Study Arms (2)

People with Vitiligo

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

Other: No intervention

People without Vitiligo

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

Other: No intervention

Interventions

No intervention OTHER

Observational analysis of usual care only.

People with Vitiligo; People without Vitiligo

Eligibility Criteria

• Age: Up to 95 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Incident cases will be defined as people with a first ever diagnosis code of vitiligo during the study period. People with a diagnosis of vitiligo prior to the study period will be excluded. Each case will be assigned an index date at the time of their vitiligo diagnosis. Controls will be matched to people without Vitiligo matched on age, sex, ethnicity and deprivation.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Momentum Data: lead
• Pfizer: collaborator

Study Sites (1)

Momentum Data Limited

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39018020 DERIVED

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Ranjit Nagra
• Organization: Pfizer Ltd

ranjit.nagra@pfizer.com

01304 616161

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: October 9, 2023
• First Posted: October 24, 2023
• Study Start: July 20, 2023
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• 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

GB (1)