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

NCT06900777 | Recruiting DMC

• 1 other identifier: XJPF-LCY-V202421
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo; Child; Progressive Disease

Keywords

Tacrolimus; Dexamethasone; Randomized Controlled Trialy; Children; Vitiligo; Safety; Efficacy; Multicenter Study; VASI Score; IGA Score; Immunosuppressive Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving VASI 50 Response

  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.

  24 weeks

Secondary Outcomes (3)

• Change in Vitiligo Area and Severity Index (VASI) Score

  24 weeks

• Proportion of Participants Achieving Investigator Global Assessment (IGA) Score Improvement

  24 weeks

• Incidence of Treatment-Emergent Adverse Events

  Throughout the 24-week treatment period

Study Arms (2)

Tacrolimus Treatment Group

EXPERIMENTAL

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.

Drug: Tacrolimus

Dexamethasone Comparison Group

ACTIVE COMPARATOR

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.

Drug: Dexamethasone

Interventions

Tacrolimus DRUG

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.

Tacrolimus Treatment Group

Dexamethasone DRUG

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).

Dexamethasone Comparison Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Vitiligo; Disease Progression

Interventions

Tacrolimus; Dexamethasone

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Zhe Jian, Associate Professor

  First Affiliated Hospital of Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhe Jian, Associate Professor

CONTACT

+862984775406; 13571826086@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized controlled study. Participants are randomly assigned to two groups, receiving tacrolimus or dexamethasone respectively. The study aims to compare the efficacy and safety of the two interventions for treating rapidly progressive vitiligo in children.

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 28, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-02

Locations

CN (1)