Trial Outcomes & Findings for Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo (NCT NCT04969419)

NCT ID: NCT04969419

Last Updated: 2025-01-14

Results Overview

Number of new onset skin cancer assessed prospectively in vitiligo cases and matched controls. The skin cancer outcome comprises of the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma.

• Recruitment status: COMPLETED
• Target enrollment: 75771 participants
• Primary outcome timeframe: 10 years from the index date
• Results posted on: 2025-01-14

Participant Flow

Participant milestones

Measure	Cases Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Overall Study STARTED	15156	60615
Overall Study COMPLETED	15156	60615
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Incidence of Melanoma and Non-melanoma Skin Cancer in People With Vitiligo

Baseline characteristics by cohort

Measure	Cases n=15156 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=60615 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Total n=75771 Participants Total of all reporting groups
Age, Continuous	47 years n=5 Participants	47 years n=7 Participants	47 years n=5 Participants
Age, Customized 18-44	6724 Participants n=5 Participants	26843 Participants n=7 Participants	33567 Participants n=5 Participants
Age, Customized 45-64	5393 Participants n=5 Participants	21596 Participants n=7 Participants	26989 Participants n=5 Participants
Age, Customized 65+	3,039 Participants n=5 Participants	12,176 Participants n=7 Participants	15215 Participants n=5 Participants
Sex: Female, Male Female	8,256 Participants n=5 Participants	33,016 Participants n=7 Participants	41272 Participants n=5 Participants
Sex: Female, Male Male	6,900 Participants n=5 Participants	27,599 Participants n=7 Participants	34499 Participants n=5 Participants
Race/Ethnicity, Customized White	8,049 Participants n=5 Participants	32,196 Participants n=7 Participants	40245 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Asian British	2,067 Participants n=5 Participants	6,096 Participants n=7 Participants	8163 Participants n=5 Participants
Race/Ethnicity, Customized Black or Black British	345 Participants n=5 Participants	1,272 Participants n=7 Participants	1617 Participants n=5 Participants
Race/Ethnicity, Customized Mixed	155 Participants n=5 Participants	557 Participants n=7 Participants	712 Participants n=5 Participants
Race/Ethnicity, Customized Not stated	367 Participants n=5 Participants	1,685 Participants n=7 Participants	2052 Participants n=5 Participants
Race/Ethnicity, Customized Other	618 Participants n=5 Participants	2,725 Participants n=7 Participants	3343 Participants n=5 Participants
Race/Ethnicity, Customized Missing data	3555 Participants n=5 Participants	16084 Participants n=7 Participants	19639 Participants n=5 Participants
Index of Multiple Deprivation	3 Quintile of deprivation n=5 Participants	3 Quintile of deprivation n=7 Participants	3 Quintile of deprivation n=5 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Number of new onset skin cancer assessed prospectively in vitiligo cases and matched controls. The skin cancer outcome comprises of the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma.

Outcome measures

Measure	Cases n=14982 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=59057 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancer in Adult People Diagnosed With Vitiligo	133 Participants	812 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Population: The number of participants analyzed for this outcome is a subset of the overall population: female sex subgroup

Number of new onset skin cancers assessed prospectively in female vitiligo cases and matched controls.

Outcome measures

Measure	Cases n=8159 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=32121 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the Female Sex Subgroup	78 Participants	429 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Population: The number of participants analyzed for this outcome is a subset of the overall population: male sex subgroup

Number of new onset skin cancers assessed prospectively in male vitiligo cases and matched controls.

Outcome measures

Measure	Cases n=6823 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=26936 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the Male Sex Subgroup	55 Participants	383 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Population: The number of participants analyzed for this outcome is a subset of the overall population:age less than 45 years subgroup

Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged <45

Outcome measures

Measure	Cases n=6711 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=26789 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the <45 Age Subgroup	11 Participants	72 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Population: The number of participants analyzed for this outcome is a subset of the overall population:age 45 tp 64 years subgroup

Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged 45-64

Outcome measures

Measure	Cases n=5 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=21 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the 45-64 Age Subgroup	42 Participants	315 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Population: The number of participants analyzed for this outcome is a subset of the overall population:age 65+ years subgroup

Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those aged >=65

Outcome measures

Measure	Cases n=2 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=11 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the >=65 Age Subgroup	80 Participants	425 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of white ethnicity

Outcome measures

Measure	Cases n=7932 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=31118 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the White Ethnicity Subgroup	103 Participants	563 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those of non-white ethnicity

Outcome measures

Measure	Cases n=3179 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=12663 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the Non-white Ethnicity Subgroup	9 Participants	66 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the most deprived subgroup category

Outcome measures

Measure	Cases n=7681 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=30325 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the Most Deprived Subgroup	46 Participants	345 Participants

PRIMARY outcome

Timeframe: 10 years from the index date

Number of new onset skin cancers assessed prospectively in vitiligo cases and matched controls by those in the least deprived subgroup category

Outcome measures

Measure	Cases n=5918 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=23307 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Skin Cancers in the Least Deprived Subgroup	66 Participants	355 Participants

SECONDARY outcome

Timeframe: At index date

Skin cancer is defined as the composite of melanoma and nonmelanoma skin cancers: squamous cell carcinoma and basal cell carcinoma.

Outcome measures

Measure	Cases n=6360 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=25439 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Prevalence of Skin Cancer in Adult People Diagnosed With Vitiligo	66 Participants	293 Participants

SECONDARY outcome

Timeframe: At index date.

Prevalence of melanoma skin cancer in adult people diagnosed with vitiligo at or before recruitment

Outcome measures

Measure	Cases n=6360 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=25439 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Prevalence of Melanoma Skin Cancer in Adult People Diagnosed With Vitiligo	85 Participants	27 Participants

SECONDARY outcome

Timeframe: At index date.

Prevalence of squamous cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment

Outcome measures

Measure	Cases n=6360 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=25439 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Prevalence of Squamous Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo	13 Participants	72 Participants

SECONDARY outcome

Timeframe: At index date.

Prevalence of basal cell carcinoma skin cancer in adult people diagnosed with vitiligo at or before recruitment

Outcome measures

Measure	Cases n=6360 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=25439 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Prevalence of Basal Cell Carcinoma Skin Cancer in Adult People Diagnosed With Vitiligo	31 Participants	161 Participants

SECONDARY outcome

Timeframe: 10 years from the index date

Number of new onset actinic keratoses in adult people assessed in vitiligo cases and matched controls.

Outcome measures

Measure	Cases n=14896 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=58618 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Number of New Onset Actinic Keratoses in Adult People Diagnosed With Vitiligo	264 Participants	1108 Participants

SECONDARY outcome

Timeframe: At index date.

Prevalence of actinic keratoses in adult people diagnosed with vitiligo at or before recruitment

Outcome measures

Measure	Cases n=6360 Participants Patients with a confirmed diagnosis of Vitiligo within the study period will be included as cases for analysis. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.	Controls n=25439 Participants The controls will be defined by matching cases with people who have never been diagnosed with vitiligo either prior to or during the study period, by age and sex, at General Practice level. Exposure of skin cancer of interest: Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
Prevalence of Actinic Keratoses in Adult People Diagnosed With Vitiligo	111 Participants	363 Participants

Adverse Events

Cases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controls

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

Dr Andrew McGovern

Momentum Data Ltd

Phone: +44 7531221970

Email: andy.mcgovern@momentumdata.co.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place