Vitiligo Registry for Adults and Children in the UK

NCT06218082 | Not Yet Recruiting DMC

• 1 other identifier: 2022DER127
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Vitiligo is the most common depigmentation disorder affecting around 1% of the population worldwide. Fifty two percent of patients develop vitiligo before the age of 20 and around 80% develop vitiligo before the age of 30 years old.1 Vitiligo often presents in childhood and tends to be a lifelong disease, requiring prolonged courses of phototherapy. Currently no national or international registry for patients with vitiligo exists. Individual dermatologists maintain a database of such patients, however no coordinated efforts have been made to combine these individual registries into a broader national registry. Finally, recently published British Association of Dermatologists (BAD) guideline for the management of vitiligo, recommended the development of a national registry for people with vitiligo undergoing systemic or light therapy to identify outcomes and safety.

Conditions

Vitiligo; Dermatologic Disease

Outcome Measures

Primary Outcomes (1)

• Multi-centred registry will be developed, with an aim to establish short- and long-term safety (pharmacovigilance) and effectiveness of vitiligo therapies

  VIRTUAL-UK is a small registry and in collaboration with the BAD, aims to utilize and modify one of the existing platforms (software), in order to assist the end user (i.e. Dermatologists) in accessing the platform and reducing the time needed for training and data input.

  12 months

Secondary Outcomes (8)

• To document the clinical and socio-demographic characteristics, co-morbidities including cancers, previous treatments of patients included in the cohort as assessed by the case report forms (CRFs).

  12 months

• To describe the clinical and socio-demographic characteristics, co-morbidities including cancers, previous treatments of patients included in the cohort

  12 months

• To assess short- and long-term safety (pharmacovigilance) of these therapies

  12 months

• To evaluate the efficacy and safety of currently used therapies for vitiligo (including combination therapies), providing a basis for better shared decision making and guidelines.

  12 months

• To evaluate the impact of these therapies on vitiligo patients' quality of life

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients (adults and children) seen at various hospitals in the UK and who are diagnosed with vitiligo will be included. Vitiligo patients who receive therapy with systemic steroids, phototherapy including laser, surgical treatments, new immunomodulators (e.g. topical or oral JAK inhibitor) once they enter UK market and any combination therapies of the above will be eligible to be included in the registry. There is no upper or lower age limit for participation. The decision to therapy or switch to another systemic agent will be the result of the treating dermatology consultant's decision, following discussion with the patient/parent/legal guardian, without using a pre-specified severity score cut off. It is the treating physician's responsibility to ensure that patients are suitable for the therapy, and that any standard of care treatment or assessments are provided alongside participation in the study as per local requirements.

You may qualify if:

• Paediatric and adult patients with vitiligo under management in secondary care.
• Written informed consent for study participation obtained from the patient or parents / legal guardian, with assent as appropriate by the patient, depending on the level of understanding.
• Participants consent to participate in long-term follow up and access to all relevant medical records as needed by the study team
• Clinical diagnosis of vitiligo made by a dermatologist
• Willingness to comply with all study requirements.
• Competent use of English language, according to patient's age (capable of understanding patient questionnaires).

You may not qualify if:

• Insufficient understanding of the study by the patient and/or parent/guardian.
• Patients with vitiligo/their parents or guardians, who do not provide consent for participation.

Sponsors & Collaborators

• The Royal Wolverhampton Hospitals NHS Trust: lead
• Incyte Biosciences International Sàrl: collaborator

Study Sites (1)

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Skin Diseases; Vitiligo

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Hypopigmentation; Pigmentation Disorders

Study Officials

• Viktoria Eleftheriadou

  The Royal Wolverhampton NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viktoria Eleftheriadou

CONTACT

01902307999; viktoria.eleftheriadou@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: January 23, 2024
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

GB (1)