VitiligoNCT06097494
Investigating Healthcare Disparities in Vitiligo
An observational study of Vitiligo, run by Momentum Data at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 95 years
- Conditions the study is for
- Vitiligo
- How many people
- 39,374 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2023to 17 Jul 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 Up to 95 years
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthcare Disparities in Vitiligo: a Population-based Cohort Study in the UK
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.
Read the detailed description
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
- Vitiligo
- Being tested
- No intervention
- Medical subject headings
- Vitiligo
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 Vitiligo | Children and adults with new onset Vitiligo registered with OPCRD during the study period. Receives: Other: No intervention | |
| People without Vitiligo | Children and adults without Vitiligo registered with OPCRD 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.
Risk of Depression Within Patients With Vitiligo
Adjusted odds ratio calculated using logistic regression.
Measured: 2 years
Risk of Anxiety Within Patients With Vitiligo
Adjusted odds ratio calculated using logistic regression.
Measured: 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 .
Measured: 2 years
Secondary outcomes (6)
Primary Care Encounters
Describe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios
Measured: 2 years
Dermatology Referrals
Percentage of participants diagnosed with vitligo and having a recorded dermatology referral event wthin two year estimated using using the Kaplan-Meier method.
Measured: 2 years
Mental Health Referrals
Describe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios
Measured: 2 years
Unemployment
Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios.
Measured: 2 years
Time Off Work
Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios.
Measured: 2 years
Sleep Disturbance
Describe any disparities in sleep disturbance reported as adjusted hazard ratios.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start20 Jul 2023
- Primary completion17 Jul 2024
- Study completion17 Jul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies 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
- 39,374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Study director, Momentum Data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097494
- Sponsor's protocol ID
- P084
- Status last verified
- Oct 2024
- First submitted
- 9 Oct 2023
- Last updated
- 17 Mar 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.
Publications
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.
PubMed 39018020
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthcare Disparities in Vitiligo: a Population-based Cohort Study in the UK
- ClinicalTrials.gov ID
- NCT06097494
- Acronym / sponsor ID
- P084
- Conditions
- Vitiligo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39,374 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Posted 17 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with Vitiligo | – | Other: No interventionChildren and adults with new onset Vitiligo registered with OPCRD during the study period. |
| People without Vitiligo | – | Other: No interventionChildren and adults without Vitiligo registered with OPCRD during the study period |
Who may qualify
- Ages
- Up to 95 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 Vitiligo, People without Vitiligo |
Primary outcome
Risk of Depression Within Patients With Vitiligo
Time frame: 2 years
Adjusted odds ratio calculated using logistic regression.
Risk of Anxiety Within Patients With Vitiligo
Time frame: 2 years
Adjusted odds ratio calculated using logistic regression.
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 .
6 secondary outcomes
Primary Care Encounters
Time frame: 2 years
Dermatology Referrals
Time frame: 2 years
Mental Health Referrals
Time frame: 2 years
Unemployment
Time frame: 2 years
Time Off Work
Time frame: 2 years
Sleep Disturbance
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39018020Eleftheriadou 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.
- 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.
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Not yet recruitingPhase 2/3
Two Trials to Evaluate TEV-53408 in Participants With Non-Segmental Vitiligo
Vitiligo
RecruitingPhase 2
A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo
Vitiligo, Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo
Nonsegmental Vitiligo
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 Vitiligo, 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 3 inclusion and 5 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 17 Mar 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 17 Mar 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?
Risk of Depression Within Patients With Vitiligo (time frame: 2 years). 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?
On the ClinicalTrials.gov record for NCT06097494, which also lists 1 linked publication.
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 17 Mar 2025.