Comparing Oral Tacrolimus Capsules and Dexamethasone Micro-pulse Therapy for Treating Rapidly Progressing Vitiligo in Children Aged 4 to 12 Years

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 mgkg per day, split into two doses, while the other group takes oral Dexamethasone tablets on weekends at 0.05 0.025 mgkg 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 childrens overall health and treatment effects are closely observed.

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