Trial Outcomes & Findings for Investigating Healthcare Disparities in Vitiligo (NCT NCT06097494)
NCT ID: NCT06097494
Last Updated: 2025-03-17
Results Overview
Adjusted odds ratio calculated using logistic regression.
Recruitment status
COMPLETED
Target enrollment
39374 participants
Primary outcome timeframe
2 years
Results posted on
2025-03-17
Participant Flow
All adults and children (aged ≥ 13 years) contributing to the Optimum Patient Care Research Database (OPCRD) between 1 January 2004 and 31 December 2020, without a diagnosis of vitiligo prior to1 January 2004 were eligible for inclusion.
Participants with a diagnosis for an alternative depigmenting disorder or were diagnosed with vitiligo within 6 months of registering with their general practice (GP) were excluded.
Participant milestones
| Measure |
People With Vitiligo
Children and adults with new onset Vitiligo registered with OPCRD during the study period.
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo (Reference Group)
Children and adults without Vitiligo registered with OPCRD during the study period
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Overall Study
STARTED
|
7890
|
31484
|
|
Overall Study
COMPLETED
|
7890
|
31484
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigating Healthcare Disparities in Vitiligo
Baseline characteristics by cohort
| Measure |
People With Vitiligo
n=7890 Participants
Children (≥ 13 years) and adults with new onset Vitiligo registered with Optimum Patient Care Research Database during the study period.
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=31484 Participants
Children (≥ 13 years) and adults without Vitiligo registered with Optimum Patient Care Research Database during the study period
No intervention: Observational analysis of usual care only.
|
Total
n=39374 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
42 years
n=7 Participants
|
42.5 years
n=5 Participants
|
|
Age, Customized
13-17 years
|
487 Participants
n=5 Participants
|
1915 Participants
n=7 Participants
|
2402 Participants
n=5 Participants
|
|
Age, Customized
18-29 years
|
1370 Participants
n=5 Participants
|
5471 Participants
n=7 Participants
|
6841 Participants
n=5 Participants
|
|
Age, Customized
30-49 years
|
3063 Participants
n=5 Participants
|
12242 Participants
n=7 Participants
|
15305 Participants
n=5 Participants
|
|
Age, Customized
50+ years
|
2970 Participants
n=5 Participants
|
11856 Participants
n=7 Participants
|
14826 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4131 Participants
n=5 Participants
|
16492 Participants
n=7 Participants
|
20623 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3759 Participants
n=5 Participants
|
14992 Participants
n=7 Participants
|
18751 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3726 Participants
n=5 Participants
|
14894 Participants
n=7 Participants
|
18620 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
196 Participants
n=5 Participants
|
708 Participants
n=7 Participants
|
904 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1197 Participants
n=5 Participants
|
4775 Participants
n=7 Participants
|
5972 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
80 Participants
n=5 Participants
|
332 Participants
n=7 Participants
|
412 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
299 Participants
n=5 Participants
|
1220 Participants
n=7 Participants
|
1519 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not recorded
|
2392 Participants
n=5 Participants
|
9555 Participants
n=7 Participants
|
11947 Participants
n=5 Participants
|
|
Index of Multiple Deprivation
1 (most deprived)
|
1525 Participants
n=5 Participants
|
6094 Participants
n=7 Participants
|
7619 Participants
n=5 Participants
|
|
Index of Multiple Deprivation
2
|
1392 Participants
n=5 Participants
|
5545 Participants
n=7 Participants
|
6937 Participants
n=5 Participants
|
|
Index of Multiple Deprivation
3
|
1355 Participants
n=5 Participants
|
5418 Participants
n=7 Participants
|
6773 Participants
n=5 Participants
|
|
Index of Multiple Deprivation
4
|
1527 Participants
n=5 Participants
|
6084 Participants
n=7 Participants
|
7611 Participants
n=5 Participants
|
|
Index of Multiple Deprivation
5 (least deprived)
|
1484 Participants
n=5 Participants
|
5928 Participants
n=7 Participants
|
7412 Participants
n=5 Participants
|
|
Index of Multiple Deprivation
Not recorded
|
607 Participants
n=5 Participants
|
2415 Participants
n=7 Participants
|
3022 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
< 18.5 (underweight)
|
269 Participants
n=5 Participants
|
1054 Participants
n=7 Participants
|
1323 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
18.5-25 (normal weight)
|
2324 Participants
n=5 Participants
|
8504 Participants
n=7 Participants
|
10828 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
25-30 (overweight)
|
2386 Participants
n=5 Participants
|
8938 Participants
n=7 Participants
|
11324 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
30-35 (class I obesity)
|
1137 Participants
n=5 Participants
|
4410 Participants
n=7 Participants
|
5547 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
35-40 (class II obesity)
|
372 Participants
n=5 Participants
|
1654 Participants
n=7 Participants
|
2026 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
> 40 (class III obesity)
|
214 Participants
n=5 Participants
|
940 Participants
n=7 Participants
|
1154 Participants
n=5 Participants
|
|
Body Mass Index, Categorical
Not recorded
|
1188 Participants
n=5 Participants
|
5984 Participants
n=7 Participants
|
7172 Participants
n=5 Participants
|
|
Smoking status, Categorical
Never smoked
|
2709 Participants
n=5 Participants
|
10000 Participants
n=7 Participants
|
12709 Participants
n=5 Participants
|
|
Smoking status, Categorical
Current smoker
|
1229 Participants
n=5 Participants
|
6114 Participants
n=7 Participants
|
7343 Participants
n=5 Participants
|
|
Smoking status, Categorical
Ex-smoker
|
3642 Participants
n=5 Participants
|
13435 Participants
n=7 Participants
|
17077 Participants
n=5 Participants
|
|
Smoking status, Categorical
Not recorded
|
310 Participants
n=5 Participants
|
1935 Participants
n=7 Participants
|
2245 Participants
n=5 Participants
|
|
Alcohol consumption, Categorical
None
|
2605 Participants
n=5 Participants
|
10014 Participants
n=7 Participants
|
12619 Participants
n=5 Participants
|
|
Alcohol consumption, Categorical
Within limits
|
2913 Participants
n=5 Participants
|
11376 Participants
n=7 Participants
|
14289 Participants
n=5 Participants
|
|
Alcohol consumption, Categorical
In excess of limits
|
1005 Participants
n=5 Participants
|
3685 Participants
n=7 Participants
|
4690 Participants
n=5 Participants
|
|
Alcohol consumption, Categorical
Harmful
|
121 Participants
n=5 Participants
|
463 Participants
n=7 Participants
|
584 Participants
n=5 Participants
|
|
Alcohol consumption, Categorical
Not recorded
|
1246 Participants
n=5 Participants
|
5946 Participants
n=7 Participants
|
7192 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsAdjusted odds ratio calculated using logistic regression.
Outcome measures
| Measure |
People With Vitiligo
n=7890 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=31484 Participants
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Risk of Depression Within Patients With Vitiligo
|
1412 Events
|
5395 Events
|
PRIMARY outcome
Timeframe: 2 yearsAdjusted odds ratio calculated using logistic regression.
Outcome measures
| Measure |
People With Vitiligo
n=7890 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=31484 Participants
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Risk of Anxiety Within Patients With Vitiligo
|
708 Events
|
2430 Events
|
PRIMARY outcome
Timeframe: 2 yearsAdjusted odds ratio of depression or anxiety in people with vitiligo calculated using logistic regression .
Outcome measures
| Measure |
People With Vitiligo
n=7890 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=31484 Participants
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Risk of Depression or Anxiety Within Patients With Vitiligo
|
1614 Events
|
6064 Events
|
SECONDARY outcome
Timeframe: 2 yearsDescribe any disparities in primary care usage (primary care visits) reported as adjusted incidence rate ratios
Outcome measures
| Measure |
People With Vitiligo
n=7890 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=31484 Participants
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Primary Care Encounters
|
134207 Events
|
439633 Events
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Dermatology referrals were assessed only in patients with vitiligo
Percentage of participants diagnosed with vitligo and having a recorded dermatology referral event wthin two year estimated using using the Kaplan-Meier method.
Outcome measures
| Measure |
People With Vitiligo
n=7890 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Dermatology Referrals
|
20 percentage of participants analyzed
Interval 19.0 to 21.0
|
—
|
SECONDARY outcome
Timeframe: 2 yearsDescribe any disparities in healthcare utilisation ( mental health referrals) reported as adjusted hazard ratios
Outcome measures
| Measure |
People With Vitiligo
n=7890 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=31484 Participants
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Mental Health Referrals
|
311 Events
|
1191 Events
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subset of participants of working age
Describe any disparities in work-related impact (unemployment) reported as adjusted hazard ratios.
Outcome measures
| Measure |
People With Vitiligo
n=6241 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=23187 Participants
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Unemployment
|
111 Events
|
436 Events
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Subset of participants of working age
Describe any disparities in work-related impact (time off work) reported as adjusted hazard ratios.
Outcome measures
| Measure |
People With Vitiligo
n=6241 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=23187 Participants
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Time Off Work
|
746 Events
|
2472 Events
|
SECONDARY outcome
Timeframe: 2 yearsDescribe any disparities in sleep disturbance reported as adjusted hazard ratios.
Outcome measures
| Measure |
People With Vitiligo
n=7890 Participants
Children (≥ 13 years) and adults with new onset Vitiligo
No intervention: Observational analysis of usual care only.
|
People Without Vitiligo
n=31484 Participants
Children (≥ 13 years) and adults without Vitiligo (reference group)
No intervention: Observational analysis of usual care only.
|
|---|---|---|
|
Sleep Disturbance
|
318 Events
|
1102 Events
|
Adverse Events
People With Vitiligo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
People Without Vitiligo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place