Non-Segmental Vitiligo
Conditions
Brief summary
The purpose of this study is to evaluate the patterns of treatment, healthcare resources utilized and the burdens associated with non-segmental vitiligo (NSV) amongst participants in China This study is a cross-sectional, multicenter, observational study of vitiligo patients in China. The cross-sectional design is sufficient to characterize the overall current burden of NSV.
Detailed description
Cross-Sectional
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients, age ≥ 12. * Chinese patients meet the diagnosis of Non-Segmental Vitiligo (NSV) and 5≤ Total Vitiligo Area Scoring Index (T-VASI\<50) with or without facial involvement. * Medical history available within the last 6 months. * Ability to understand the questionnaires, with parental support as required for adolescents (between ≥ 12 and \< 18 years of age at inclusion visit). * Willing to provide a patient authorization form to use and disclose personal health information (or informed consent, where applicable) to participate in the study; for adolescent subjects, authorization and/or consent will be provided by a parent or legal guardian, where applicable.
Exclusion criteria
* Unable or unwilling to comply with study requirements and electronic Patient-Reported Outcome (ePRO) collection. * Segmental or localized vitiligo. * Greater than 33% leukotrichia in areas of vitiligo on the face or on the body. * History of active skin disease other than vitiligo that could interfere with the assessment of vitiligo. * Patients who are participating in interventional clinical trial(s) at time of study visit. * Patients who are currently receiving treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Vitiligo Area Scoring Index (T-VASI) | At Inclusion Visit (Day 1) | The T-VASI is calculated using a formula that includes contributions from all body regions, with a possible range from 0 to 100, with higher scores indicating more severe disease. |
| Vitiligo Quality of Life Scale (VitiQoL) | At Inclusion Visit (Day 1) | The VitiQoL is an 16-item instrument assessing impact of vitiligo on quality of life. 15 items are scored on a 7-point Likert scale, ranging from not at all to all the time. An additional item (not contributing to total score) assesses current severity of condition on a 7-point scale ranging from no skin involvement to most severe case |
Countries
China
Outcome results
None listed