Vitiligo Registry for Adults and Children in the UK — VIRTUAL-UK  

Vitiligo Clinical Trial

Official title: Vitiligo Registry for Adults and Children in the UK (VIRTUAL-UK)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

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. Vitiligo often presents in childhood and tends to be a lifelong disease, requiring prolonged courses of phototherapy. Vitiligo is an autoimmune skin disorder and is often associated with multiple other autoimmune disorders such as thyroid disorders, diabetes, IBS, pernicious anemia, alopecia areata amongst others. Current treatments include topical corticosteroids and calcineurin inhibitors, phototherapy, combination of phototherapy with oral corticosteroids, laser and surgical interventions. Other treatment modalities such as Methotrexate have also been trialed. Currently available treatments are being used off license with uncertain therapeutic success. Previously, it has been shown that vitiligo has an inverse relationship with melanoma, which means that people with vitiligo are less likely to develop melanoma. A recent systematic review and meta-analysis looking into the risk of skin cancer in people with vitiligo showed that compared with people without vitiligo, people with vitiligo had a significantly lower risk of nonmelanoma skin cancer. The same pattern occurred for melanoma (but was not statistically significant). However, this review was limited by the small number of included studies and high heterogeneity due to methodological and clinical differences between the included studies. In addition, there is lack of data on the skin cancer risk for vitiligo patients who receive prolonged phototherapy courses, especially regarding high cumulative exposures in children with less deeply pigmented skin. This is especially important when NB-UVB is combined with topical tacrolimus treatment, due to theoretical increased risk of skin cancer. In addition, there is an urgent need for new, effective and licensed treatment for vitiligo. In the dawn on new therapeutic era of new emerging treatments such as topical and oral JAK inhibitors, evidence will be needed on the effectiveness, safety and cost effectiveness of such therapies compared to other treatments. In order to gather evidence on clinical effectiveness of vitiligo treatments and to assist with updating of clinical guidance pathway, as well as to gather information on possible risk factors, adverse events, maintenance regime and assist with conduction of post marketing studies, prospective multicentre registry is needed for vitiligo patients who are treated with phototherapy, combination treatments (with phototherapy), oral agents (such as oral corticosteroids) including new emerging JAK inhibitors (once there are available in the UK). Oral corticosteroids combined with phototherapy are recommended by the recently published BAD guidelines for cases of rapidly progressive vitiligo. Case reports were published on initiation of methotrexate and oral JAK inhibitors for the treatment of vitiligo. In addition, there is no firm data on disease progression and especially predictors of rapidly progressive vitiligo are largely unknown, which is a challenging scenario for the patient and their clinician. 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.2 As an initial, preliminary step for the development of the online UK registry for vitiligo patients, development of a pilot multi-centred registry in the UK is needed. In addition, such registry will be co-ordinated with a pilot multi-centred registry in France and the USA. Each registry will be developed separately (country-specific) and there will be no data sharing between the registries, however there will be co-ordination between the CIs of the registries with regards to the outcomes collected. Another challenge in vitiligo has been consistency in the use of core outcome domains and measures instruments to define treatment success or failure. The international Initiative for Outcomes for vitiligo (INFO) has previously addressed this heterogeneity and defined 3 outcome domains as being essential: repigmentation, side effects/harms and maintenance of gained repigmentation. Four items were further recommended for inclusion but were not considered to be essential: cosmetic acceptability of the results, quality of life, cessation of spreading of vitiligo and tolerability or burden of treatment.5 INFO has subsequently published recommendations on how to measure repigmentation in target lesion. Percentage of repigmentation in quartiles (0-25%, 26-50%, 51-79%, 80-100%) should be measured as well as cosmetic acceptability of results should be assessed using the Vitiligo Noticeability Scale.6 There are also several other established instruments exist (such as VASI, VIPs, VITs) to measure these domains and these are suitable for use in a registry. A long-term safety data will be vital to provide pharmacovigilance, particularly regarding rare or delayed adverse effects of treatment. Hence a prospective multicentre registry study is greatly needed to evaluate the real-world use of phototherapy (including combination treatments with phototherapy), topical JAK inhibitors, systemic immuno-modulatory therapies in adults and children undergoing treatment for vitiligo to provide effectiveness and safety data beyond the confines of short-term randomised controlled trials (RCTs). Such a registry will ultimately inform treatment guidelines, provide pharmacogenetic and pharmacodynamic research data, and help to identify those patients likely to experience rapid disease progression, ultimately improving and personalising patient care. With novel topical and oral immunomodulatory therapies having just entering vitiligo clinical practice, the timing is ideal to harness the high-quality data collection offered by the UK NHS. ;

Related Conditions & MeSH terms

• Dermatologic Disease
• Skin Diseases
• Vitiligo

• NCT number: NCT06218082
• Study type: Observational [Patient Registry]
• Source: The Royal Wolverhampton Hospitals NHS Trust
• Contact: Viktoria Eleftheriadou
• Phone: 01902307999
• Email: viktoria.eleftheriadou@nhs.net
• Status: Not yet recruiting
• Start date: April 1, 2024
• Completion date: March 2029