Status:
RECRUITING
Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT
Lead Sponsor:
Xijing Hospital
Conditions:
Vitiligo
Child
Eligibility:
All Genders
4-12 years
Phase:
NA
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 v...
Detailed Description
Background: Vitiligo is an autoimmune skin condition causing pigment loss, significantly impacting children's well-being. Current treatments like systemic corticosteroids (e.g., Dexamethasone) carry ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06900777
Start Date
April 1 2025
End Date
April 1 2026
Last Update
June 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xijing Hospital
Xi'an, Shaanxi, China, 710032