Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT
Recruiting now · Not applicable
Conditions studied: Vitiligo, Child, Progressive Disease
In brief
This clinical study aims to compare the safety and effectiveness of two treatments-oral Tacrolimus capsules and Dexamethasone micro-pulse therapy-in children aged 4-12 years with rapidly progressing vitiligo. The study is a multicenter, randomized, controlled trial involving 90 participants, who will be divided equally into two groups. One group will receive daily Tacrolimus, while the other will take Dexamethasone on weekends. Over 24 weeks, doctors will monitor improvements in skin repigmentation, side effects, and overall health through regular check-ups and blood tests. The goal is to determine which treatment better controls disease progression and improves quality of life for children with vitiligo. Key Points: * For children with rapidly spreading vitiligo. * Compares two common medications. * Follows participants for 6 months. * Focuses on safety and effectiveness.
Key facts
- Study ID
- NCT06900777
- Run by
- Xijing Hospital
- People needed
- 90
- Starts
- 2025-04-01
- Expected to finish
- 2026-04-01
- Last updated by the study team
- 2025-06-19
Who can join
Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Xijing Hospital — Xi'an, Shaanxi, China (enrolling)
Full record on ClinicalTrials.gov
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