Actively Recruiting
Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT
Led by Xijing Hospital · Updated on 2025-06-19
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 to 12 years diagnosed with rapidly progressing non-segmental vitiligo (VIDA score 4, indicating progression within the past 6 weeks)
- Vitiligo affects between 1% and 50% of total body surface area
- Written informed consent provided by the child's guardian
You will not qualify if you...
- Stable-phase childhood vitiligo or other types such as segmental, mucosal, undetermined, or generalized vitiligo
- Use of systemic immunosuppressive therapy within the past 4 weeks
- Known allergy to tacrolimus, macrolide drugs, or study drug ingredients
- Severe liver or kidney dysfunction preventing oral tacrolimus use
- Obesity or systemic diseases including tuberculosis, infections, hypertension, or congenital heart disease
- Any condition increasing risk or interfering with the study as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
Z
Zhe Jian, Associate Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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