Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China
- Conditions
- Non-Segmental Vitiligo
- Registration Number
- NCT07058051
- Lead Sponsor
- AbbVie
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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"
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shandong Dermatological Hospital /ID# 276918
🇨🇳Jinan, Shandong, China
Shandong Dermatological Hospital /ID# 276918🇨🇳Jinan, Shandong, China