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.

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.