VOICE: Vitiligo Outcome Instruments and Consensus for Evidence

Disease State: Vitiligo

 

Background

Vitiligo is a chronic immune mediated condition that causes the skin to lose color in circumscribed patches. While there are a number of new drugs in development for vitiligo, at present there is no cure.

A group of physicians, researchers, patients, pharmaceutical companies, and payers from around the globe have come together with the goal of developing a COS for trials in vitiligo. Our project involves over 100 participants, a third of whom are Vitiligo patients. Our stakeholders represent 5 continents, making our collaboration truly international.

 

Project Goal

Vitiligo Outcome Instruments and Consensus for Evidence (VOICE) aims to establish a core outcome set for vitiligo in clinical trials, registries and clinical practice.

VOICE has completed a systematic review and a nominal process which yielded a final set of approximately 20 items deemed relevant to vitiligo trials by stakeholders. Through three rounds of e-Delphi and three international in-person meetings in Denver, Miami, and Singapore, consensus was achieved on the core domain set. Updates to the core domain set is planned for 2022-2023. VOICE is also developing the core measures set and is currently evaluating responsiveness of several instruments measuring repigmentation including the Total and Facial Vitiligo Area of Severity Instrument (T and F-VASI), Vitiligo Extent Score (VES) and the VES plus for repigmentation. Quality of life measures, including the Vitiligo Quality Of Life (VitiQOL) and the Vitiligo Impact Patient score (VIPs) for QOL, are also being evaluated. Other instruments in various stages of development or validation include measures for global assessment, global burden of treatment, and cessation of spread.

The project encompassing the COS for trials, registries, and clinical practice is known as VITAL (Vitiligo International Task force for an Agreed List of core data).

 

Project Leads

Khaled Ezzedine
Khaled Ezzedine
Nanja van Geel
Nanja van Geel

Key Project Team Members

Viktoria Eleftheriadou
Viktoria Eleftheriadou
Iltefat Hamzavi
Iltefat Hamzavi
Amit Pandya
Amit Pandya
Julien Seneschal
Julien Seneschal
Albert Wolkerstorfer
Albert Wolkerstorfer

C3 Methods Partner

Khaled Ezzedine

 

Contact

Khaled Ezzedine: khaled.ezzedine@aphp.fr

 

Publications

Core Domain Set

  • Eleftheriadou V, Thomas K, van Geel N, Hamzavi I, Lim H, Suzuki T, Katayama I, Anbar T, Abdallah M, Benzekri L, Gauthier Y, Harris J, Silva de Castro CC, Pandya A, Goh BK, Lan CC, Oiso N, Al Issa A, Esmat S, Le Poole C, Lee AY, Parsad D, Taieb A, Picardo M, Ezzedine K; Vitiligo Global Issues Consensus Group. Developing core outcome set for vitiligo clinical trials: International e-Delphi consensus. Pigment Cell Melanoma Res. 2015;28(3):363-9. https://pubmed.ncbi.nlm.nih.gov/25645179/
  • van Geel N, Boniface K, Seneschal J, Jacquemin C, Speeckaert R, Wolkerstorfer A, Bekkenk M, Lommerts JE, Hamzavi I, Pandya A, Eleftheriadou V, Ezzedine K, Giannarelli D, Gnarra M, Sperduti I, Prinsen C, Harris J, Taieb A, Picardo M. Meeting report: Vitiligo Global Issues Consensus Conference Workshop "Outcome measurement instruments" and Vitiligo International Symposium, Rome, Nov 30-Dec 3rd. Pigment Cell Melanoma Res. 2017;30(4):436-443. https://pubmed.ncbi.nlm.nih.gov/28379638/
  • Gan EY, Eleftheriadou V, Esmat S, Hamzavi I, Passeron T, Böhm M, Anbar T, Goh BK, Lan CE, Lui H, Ramam M, Raboobee N, Katayama I, Suzuki T, Parsad D, Seth V, Lim HW, van Geel N, Mulekar S, Harris J, Wittal R, Benzekri L, Gauthier Y, Kumarasinghe P, Thng ST, Silva de Castro CC, Abdallah M, Vrijman C, Bekkenk M, Seneschal J, Pandya AG, Ezzedine K, Picardo M, Taïeb A; VGICC. Repigmentation in vitiligo: position paper of the Vitiligo Global Issues Consensus Conference. Pigment Cell Melanoma Res. 2017;30(1):28-40. https://pubmed.ncbi.nlm.nih.gov/27864868/
  • Eleftheriadou V, Hamzavi I, Pandya AG, Grimes P, Harris JE, Huggins RH, Lim HW, Elbuluk N, Bhatia B, Tovar-Garza A, Nahhas AF, Braunberger T, Ezzedine K. International Initiative for Outcomes (INFO) for vitiligo: workshops with patients with vitiligo on repigmentation. Br J Dermatol. 2019;180(3):574-579. https://pubmed.ncbi.nlm.nih.gov/30030843/


Repigmentation

  • van Geel N, Lommerts J, Bekkenk M, Wolkerstorfer A, Prinsen CAC, Eleftheriadou V, Taïeb A, Picardo M, Ezzedine K, Speeckaert R. Development and Validation of the Vitiligo Extent Score (VES): an International Collaborative Initiative. J Invest Dermatol. 2016;136(5):978-984. https://pubmed.ncbi.nlm.nih.gov/26827762/
  • van Geel N, Wolkerstorfer A, Lommerts JE, Ezzedine K, Eleftheriadou V, Hamzavi I, Harris J, Picardo M, Taieb A, Prinsen CAC, Bekkenk M, Speeckaert R. Validation study of the Vitiligo Extent Score-plus. J Am Acad Dermatol. 2018;78(5):1013-1015. https://pubmed.ncbi.nlm.nih.gov/29180094/
  • van Geel N, Bekkenk M, Lommerts JE, Ezzedine K, Harris J, Hamzavi I, Eleftheriadou V, Picardo M, Taieb A, Prinsen CAC, Wolkerstorfer A, Speeckaert R. The Vitiligo Extent Score (VES) and the VESplus are responsive instruments to assess global and regional treatment response in patients with vitiligo. J Am Acad Dermatol. 2018;79(2):369-371. https://pubmed.ncbi.nlm.nih.gov/29307645/
  • Bae JM, Zubair R, Ju HJ, Kohli I, Lee HN, Eun SH, Lyons AB, Vellaichamy G, Han TY, Lim HW, Hamzavi IH. Development and validation of the fingertip unit for assessing Facial Vitiligo Area Scoring Index. J Am Acad Dermatol. 2022;86(2):387-393. https://pubmed.ncbi.nlm.nih.gov/34246695/


Vitiligo-Specific Quality of Life

  • Salzes C, Abadie S, Seneschal J, Whitton M, Meurant JM, Jouary T, Ballanger F, Boralevi F, Taieb A, Taieb C, Ezzedine K. The Vitiligo Impact Patient Scale (VIPs): Development and Validation of a Vitiligo Burden Assessment Tool. J Invest Dermatol. 2016;136(1):52-8. https://pubmed.ncbi.nlm.nih.gov/26763423/
  • Ezzedine K, Ahmed M, Tovar-Garza A, Hajj C, Whitton M, Pandya A, Altalhab S, Seneschal J, Harris J, Taieb C. Cross-cultural validation of a short-form of the Vitiligo Impact Patient scale (VIPs). J Am Acad Dermatol. 2019;81(5):1107-1114. https://pubmed.ncbi.nlm.nih.gov/30763647/            


Global Assessment

  • van Geel N, Wolkerstorfer A, Ezzedine K, Pandya AG, Bekkenk M, Grine L, Van Belle S, Lommerts JE, Hamzavi I, Harris JE, Eleftheriadou V, Esmat S, Kang HY, Kumarasinghe P, Lan CE, Parsad D, Raboobee N, Flora Xiang L, Suzuki T, Prinsen CA, Taieb A, Picardo M, Speeckaert R; participants of the Rome International VGICC /VIS Workshop. Validation of a physician global assessment tool for vitiligo extent: Results of an international vitiligo expert meeting. Pigment Cell Melanoma Res. 2019;32(5):728-733. https://pubmed.ncbi.nlm.nih.gov/30945409/
  • Investigator Global Assessment, in progress


Disease spread

  • van Geel N, Passeron T, Wolkerstorfer A, Speeckaert R, Ezzedine K. Reliability and validity of the Vitiligo Signs of Activity Score (VSAS). Br J Dermatol. 2020;183(5):883-890. https://pubmed.ncbi.nlm.nih.gov/32064583/

 

Updated on May 1,2022