Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT

Launched by XIJING HOSPITAL · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different treatments for children aged 4 to 12 years who have rapidly progressing vitiligo, which is a skin condition that causes loss of color in patches. The study will compare the safety and effectiveness of oral Tacrolimus capsules taken daily with Dexamethasone micro-pulse therapy, which involves taking the medication only on weekends. The goal is to see which treatment works better to slow down the disease's progression and improve the children's skin color over a period of 24 weeks.

To participate, children must have been diagnosed with rapidly progressing vitiligo, meaning their condition has worsened in the last six weeks and affects between 1% and 50% of their skin. Not everyone can join; for example, children with stable vitiligo or certain health issues won't be eligible. During the study, doctors will regularly check the children's skin and overall health, including blood tests, to monitor how well they are responding to the treatments.

Gender

ALL

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.