Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China

NCT07058051 | Completed

• 1 other identifier: H25-976
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Non-Segmental Vitiligo

Outcome Measures

Primary Outcomes (2)

• Total Vitiligo Area Scoring Index (T-VASI)

  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.

  At Inclusion Visit (Day 1)

• Vitiligo Quality of Life Scale (VitiQoL)

  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"

  At Inclusion Visit (Day 1)

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with non-segmental vitiligo and 5≤T-VASI\<50 will be included. The NSV patients will be consecutively enrolled via convenience sampling in this study.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Dermatology Hospital of Southern Medical University /ID# 276921

Guangzhou, Guangdong, 510091, China

Location

Wuhan Integrated TCM & Western Medicine Hospital（Wuhan No.1 Hospital) /ID# 276919

Wuhan, Hubei, 430022, China

Location

Suzhou Municipal Hospital /ID# 276948

Suzhou, Jiangsu, 215002, China

Location

Shandong Dermatological Hospital /ID# 276918

Jinan, Shandong, 250022, China

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: July 17, 2025
• Primary Completion: November 13, 2025
• Study Completion: November 13, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

CN (4)