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

NCT06900777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

  • Vitiligo
  • Child
  • Progressive Disease

Interventions

DRUG

Tacrolimus

Participants receive oral tacrolimus capsules at a dosage of 0.1 ± 0.05 mg/kg per day, divided into two administrations. The treatment duration is 24 weeks. Blood drug concentration is monitored to maintain trough levels between 7-15 ng/mL. Safety assessments include regular blood tests (hematology, liver/kidney function, blood glucose) and adverse event tracking.

DRUG

Dexamethasone

Participants receive oral dexamethasone tablets at a dosage of 0.05 ± 0.025 mg/kg per day, administered as a single dose on weekends (Saturday and Sunday). The treatment duration is 24 weeks. Safety evaluations include monitoring of blood parameters (hematology, liver/kidney function, blood glucose), weight, and adrenal function (cortisol, ACTH levels).

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Zhe Jian, Associate Professor · First Affiliated Hospital of Air Force Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06900777 on ClinicalTrials.gov