NCT06900777 Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT
| NCT ID | NCT06900777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Vitiligo |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Zhe Jian, Associate Professor
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Air Force Medical University
Frequently Asked Questions
Who can join the NCT06900777 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 12 Years, studying Vitiligo. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06900777 currently recruiting?
Yes, NCT06900777 is actively recruiting participants. Contact the research team at 13571826086@163.com for enrollment information.
Where is the NCT06900777 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06900777 clinical trial?
NCT06900777 is sponsored by Xijing Hospital. The principal investigator is Zhe Jian, Associate Professor at First Affiliated Hospital of Air Force Medical University. The trial plans to enroll 90 participants.