Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 4-12 years diagnosed with rapidly progressive non-segmental vitiligo (VIDA score ≥4, indicating disease progression within the past 6 weeks).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tacrolimus
DrugParticipants 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.
Dexamethasone
DrugParticipants 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).
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Tacrolimus Treatment GroupExperimental treatment 1 intervention
Group B: Dexamethasone Comparison GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
24 weeksSecondary outcomes
1
Change in Vitiligo Area and Severity Index (VASI) Score
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.
Time frame
24 weeks2
Proportion of Participants Achieving Investigator Global Assessment (IGA) Score Improvement
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.
Time frame
24 weeks3
Incidence of Treatment-Emergent Adverse Events
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.
Time frame
Throughout the 24-week treatment periodSponsors and contacts
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Source ClinicalTrials.gov