Actively Recruiting
Oral Tacrolimus Capsule Versus Dexamethasone Micro-pulse Therapy for the Treatment of Rapidly Progressing Vitiligo in Children: A Multicenter, Randomized, Controlled Study
Led by Xijing Hospital · Updated on 2025-06-19
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial studies children aged 4 to 12 years with rapidly progressing vitiligo, an autoimmune skin condition causing pigment loss. The research compares the safety and effectiveness of two treatments: oral Tacrolimus capsules and Dexamethasone micro-pulse therapy. The goal is to find which treatment better controls disease progression and improves quality of life for affected children. The study is multicenter and randomized, enrolling 90 participants divided equally into two groups. One group receives oral Tacrolimus capsules daily at a dose of 0.1 ± 0.05 mg/kg per day, split into two doses, while the other group takes oral Dexamethasone tablets on weekends at 0.05 ± 0.025 mg/kg per dose. Both treatments continue for 24 weeks with follow-up visits at 4, 8, 12, 16, 20, and 24 weeks. Blood drug concentrations and safety assessments, including blood tests and adrenal function monitoring, are part of the treatment protocols. Participants attend regular check-ups over 24 weeks to monitor skin repigmentation using the Vitiligo Area Scoring Index (VASI) and Investigator Global Assessment (IGA) scores. Safety is tracked by blood tests, metabolic panels, and adverse event reporting. The main outcome is the proportion of children achieving at least 50% improvement in vitiligo severity at 24 weeks. This trial lasts six months, during which children's overall health and treatment effects are closely observed.
CONDITIONS
Brief 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 with rapidly progressive non-segmental vitiligo (VIDA score 54) showing disease progression within the last 6 weeks
- Total body surface area affected by vitiligo between 1% and 50%
- Written informed consent provided by the child's guardian
You will not qualify if you...
- Stable-phase childhood vitiligo or segmental, mucosal, undetermined, or generalized vitiligo
- Systemic immunosuppressive therapy used within the past 4 weeks
- Known hypersensitivity to tacrolimus, other macrolide drugs, or study medication ingredients
- Severe liver or kidney dysfunction preventing use of oral tacrolimus
- Obesity or systemic diseases such as tuberculosis, acute or chronic infections, hypertension, congenital cardiovascular disease
- Any condition that investigators determine would increase risk or interfere with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive oral tacrolimus capsules or oral dexamethasone tablets according to their assigned group to treat rapidly progressing vitiligo. Safety assessments including blood tests and monitoring of adverse events are conducted during treatment.
Follow-up visits at weeks 4, 8, 12, 16, 20, and 24
Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
Z
Zhe Jian, Associate Professor
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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