Oral tacrolimus versus dexamethasone micro‑pulse for rapidly progressing pediatric vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, controlled trial enrolling 90 children with rapidly progressive non‑segmental vitiligo who are randomized 1:1 to oral tacrolimus or dexamethasone micro‑pulse therapy. The tacrolimus group receives weight‑based daily dosing divided twice daily, while the dexamethasone group receives weekend pulse dosing; both are followed for 24 weeks with visits at weeks 4, 8, 12, 16, 20 and 24. The primary outcome is the proportion achieving at least 50% improvement in VASI (VASI‑50) at 24 weeks, and secondary outcomes include higher VASI response thresholds, investigator global assessment, and safety monitored by blood tests and adverse event reporting. Data are analyzed by intention‑to‑treat with chi‑square testing for between‑group comparisons.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children aged 4-12 years diagnosed with rapidly progressive non-segmental vitiligo (VIDA score ≥4, indicating disease progression within the past 6 weeks).

Total body surface area (BSA) affected by vitiligo between 1% and 50%. Guardians provide written informed consent for the child's participation.

Exclusion Criteria:

* Stable-phase childhood vitiligo. Segmental, mucosal, undetermined, or generalized vitiligo. Systemic immunosuppressive therapy within the past 4 weeks. Known hypersensitivity to tacrolimus, other macrolide drugs, or study drug excipients.

Comorbidities precluding oral tacrolimus use (e.g., severe hepatic/renal dysfunction).

Obesity or systemic diseases (e.g., tuberculosis, acute/chronic infections, hypertension, congenital cardiovascular disease).

Any condition deemed by investigators to increase participant risk or interfere with trial execution.

Where it's running

• Xijing Hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: Zhe Jian, Associate Professor — First Affiliated Hospital of Air Force Medical University
• Study coordinator: Zhe Jian, Associate Professor
• Email: 13571826086@163.com
• Phone: +862984775406

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.