A CollaboraTive Initiative of worldwide Vitiligo Experts and patients to define vitiligo activity (ACTIVE): study protocol.

OBJECTIVES

The CollaboraTive Initiative of worldwide Vitiligo Experts and patients to define vitiligo activity (ACTIVE) project aims to develop standardized definitions and criteria for assessing disease activity in vitiligo using a consensus-based, multi-stakeholder approach.

METHODS

The project is divided into three main topics. Topic 1 focuses on standardizing the definition and terminology of clinical signs of disease activity, using literature reviews, iterative e-Delphi surveys, and a consensus meeting. Topic 2 aims to classify disease activity into distinct activity categories by differentiating between slowly and highly progressive vitiligo. This will involve a literature search, a patient focus group, an e-Delphi survey, and a final consensus meeting. Topic 3 addresses remaining challenges in defining and assessing disease activity in vitiligo. This will include, for instance, the definitions of stability versus activity. In addition, unresolved issues and feedback identified by working groups 1 and 2 will further contribute to working group 3 with the aim of reaching a global consensus on all other key concepts of disease activity in vitiligo.

RESULTS/

CONCLUSION

By engaging international vitiligo experts and patients/patient representatives throughout the process, the ACTIVE study is designed to enhance consistency in disease activity definitions across multiple centers. This will improve the comparability of outcomes, facilitate management, and support clinical trials evaluating new treatments with more reliable inclusion.