Vitiligo Registry for Adults and Children in the UK
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Royal Wolverhampton Hospitals NHS Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
1
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).
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).
Time frame
12 months2
To describe the clinical and socio-demographic characteristics, co-morbidities including cancers, previous treatments of patients included in the cohort
To describe the clinical and socio-demographic characteristics, co-morbidities including cancers, previous treatments of patients included in the cohort
Time frame
12 months3
To assess short- and long-term safety (pharmacovigilance) of these therapies
To assess short- and long-term safety (pharmacovigilance) of these therapies
Time frame
12 months4
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.
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.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Royal Wolverhampton Hospitals NHS Trust
Lead sponsor
Incyte Biosciences International Sàrl
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: