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A prospective cohort study of tofacitinib citrate combined with prednisone acetate in the treatment of advanced non-segmental vitiligo

A prospective cohort study of tofacitinib citrate combined with prednisone acetate in the treatment of advanced non-segmental vitiligo

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097209
Enrollment
Unknown
Registered
2025-02-14
Start date
2025-02-18
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitiligo

Interventions

Tofacitinib citrate group:None
Prednisone acetate group:None

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years; 2.Diagnosed as advanced non-segmental vitiligo [any one of the following conditions must be met to be diagnosed as advanced vitiligo: 1) Vitiligo disease activity score (VIDA) >= 3 points; 2) There are signs such as trichromatic signs, multicolored paper pattern desquamation or homomorphic reaction; 3)The range of skin lesions under the wood lamp is larger than that visible to the naked eye. 3.The severity of vitiligo is moderate or above [refer to the severity rating in the "Consensus on the Diagnosis and Treatment of Vitiligo (2021 Edition)", and the palm area is about 1% of the body surface area. Grade 1 is mild, leukoplakia 50% body surface area]; 4.Patients who are willing to participate in this study, and who agree to be treated with this protocol; 5.Patient has good compliance with the planned treatment, is willing to cooperate with follow-up, can understand the study process of this study and sign a written informed consent form;

Exclusion criteria

Exclusion criteria: 1. Systemic use of glucocorticoids or other systemic immunomodulatory agents within the past 3 months; 2. Combined with malignant tumors; 3. Mental illness; 4. Patients with hypertension, diabetes, active gastric ulcer, active tuberculosis and other systemic glucocorticoid use contraindications, or with coronary heart disease, liver function, kidney function and other biochemical abnormalities and other organ dysfunction; 5. Suffering from chronic or recurrent infectious diseases (such as hepatitis B, malaria, tuberculosis and other infectious diseases); 6. Patients with cognitive impairment (aphasia, agnosia, apraxia, dementia and other mental and neurological changes); 7. Women of childbearing age who are pregnant, lactating, or unwilling to use effective contraception throughout the trial; 8. Participated in another trial within 30 days before the first dose of study drug; 9. Patients judged by the investigator to be ineligible for the study;

Design outcomes

Primary

MeasureTime frame
The percentage of patients in each group who did not develop new white patches or had previously enlarged white patches at weeks 4, 8, 12, 16, 20, and 24 after receiving corresponding treatment plans;

Secondary

MeasureTime frame
vitiligo disease activity score;Dermatology Life Quality Index;skindex-29 score;Vitiligo Area Scoring Index;

Countries

China

Contacts

Public ContactYin Rui

The First Affiliated Hospital of Army Medical University

swyinrui@163.com+86 23 68766333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026