Oral Tacrolimus Vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: a Multicenter RCT

Not Applicable

Not yet recruiting

• Conditions: Vitiligo; Child; Progressive Disease
• Interventions: Drug: Tacrolimus; Drug: Dexamethasone

• Registration Number: NCT06900777
• Lead Sponsor: Xijing Hospital

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 vitiligo. The study is a multicenter, randomized, controlled trial involving 90 participants, who will be divided equally into two groups. One group will receive daily Tacrolimus, while the other will take Dexamethasone on weekends. Over 24 weeks, doctors will monitor improvements in skin repigmentation, side effects, and overall health through regular check-ups and blood tests. The goal is to determine which treatment better controls disease progression and improves quality of life for children with vitiligo.

Key Points:

* For children with rapidly spreading vitiligo.

* Compares two common medications.

* Follows participants for 6 months.

* Focuses on safety and effectiveness.

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 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-28
• Last Update Posted: 2025-03-28
• Study Start: 2025-04-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus Treatment Group	Tacrolimus	Participants in this arm receive oral tacrolimus therapy following the specified dosage and administration schedule in the study protocol for treating rapidly progressive vitiligo in children.
Dexamethasone Comparison Group	Dexamethasone	Participants in this arm receive oral dexamethasone as the comparative intervention, administered according to the study protocol for evaluating its efficacy and safety in treating rapidly progressive vitiligo in children.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving VASI 50 Response	24 weeks	VASI (Vitiligo Area and Severity Index) 50 response is defined as a 50% or greater reduction in VASI score from baseline. Assessment is conducted by trained dermatologists using standardized VASI scoring criteria.

Secondary Outcome Measures

Name	Time	Method
Change in Vitiligo Area and Severity Index (VASI) Score	24 weeks	Calculate the difference between the VASI score at 24 weeks and the baseline VASI score. This reflects the improvement in vitiligo area and severity over the treatment period.
Proportion of Participants Achieving Investigator Global Assessment (IGA) Score Improvement	24 weeks	Assess participants' IGA scores at 24 weeks. Participants with an IGA score of "mild" or better (score ≤ 2) are defined as achieving improvement, and the proportion is calculated.
Incidence of Treatment-Emergent Adverse Events	Throughout the 24-week treatment period	Record all adverse events (e.g., gastrointestinal symptoms, metabolic abnormalities) occurring during the 24-week treatment period. Calculate the incidence rate and analyze their relationship with the intervention.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China