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

Oral Tacrolimus Capsule Versus Dexamethasone Micro-pulse Therapy for the Treatment of Rapidly Progressing Vitiligo in Children: A Multicenter, Randomized, Controlled Study

This trial tests whether daily oral tacrolimus or weekend dexamethasone pulses better control rapidly spreading vitiligo in children aged 4–12.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 4 Years to 12 Years
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06900777 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 4–12 years with rapidly progressive non‑segmental vitiligo (VIDA score ≥4) affecting 1–50% body surface area whose guardians can provide written informed consent.

Not a fit: Children with stable‑phase, segmental, mucosal, generalized, or otherwise excluded forms of vitiligo, or those with severe hepatic/renal dysfunction, recent systemic immunosuppression, obesity, or other disqualifying comorbidities are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, this could offer a treatment that better halts progression and improves repigmentation with a preferable safety profile for children with rapidly spreading vitiligo.

How similar studies have performed: Corticosteroid pulse regimens have been used to halt pediatric vitiligo progression, while oral tacrolimus for vitiligo is relatively novel and lacks robust pediatric randomized evidence.

Eligibility criteria

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 this trial is running

Xi'an, Shaanxi

• 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

Conditions Vitiligo; Child; Progressive Disease; Tacrolimus; Dexamethasone; Randomized Controlled Trialy; Children; Safety