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

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 risks of long-term side effects. Tacrolimus, an immunosuppressant with a safer profile in other pediatric conditions, shows promise but lacks evidence for oral use in vitiligo. This trial addresses this gap by comparing Tacrolimus and Dexamethasone. Study Design: * Multicenter, randomized, controlled trial across 5 hospitals in China. * 90 participants (4-12 years) with rapidly progressing non-segmental vitiligo (VIDA score 4). * Interventions: * Tacrolimus group: 0.1±0.05 mg/kg/day, divided into two doses. * Dexamethasone group: 0.05±0.025 mg/kg/weekend pulse dosing. * Duration: 24 weeks with follow-ups at 4, 8, 12, 16, 20, and 24 weeks. Outcome Measures: * Primary: Proportion achieving ≥50% improvement in Vitiligo Area Scoring Index (VASI 50) at 24 weeks. * Secondary: VASI 75/90 response rates, Investigator Global Assessment (IGA) scores, and safety parameters (blood tests, metabolic panels, adverse events). Statistical Analysis: Data will be analyzed using chi-square tests to compare efficacy and safety between groups (significance: p ≤ 0.05). All analyses adhere to intention-to-treat principles. Ethics \& Compliance: Approved by the Ethics Committee of the First Affiliated Hospital of Air Force Medical University. Informed consent is obtained from all participants' guardians.