An interventional study of Tacrolimus and Dexamethasone in Vitiligo, Child and Progressive Disease, sponsored by Xijing Hospital. Recruiting at 1 site in China. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-06-19.
Sponsored by Xijing Hospital · Not applicable, Interventional, and Treatment
Among 11 studies testing tacrolimus in Vitiligo — 2 open to participants now, 2 under way, none of them phase 3. Tacrolimus · Vitiligo.
Among the 11 studies testing tacrolimus in Vitiligo, this one is the 3rd largest by planned enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2025, is one of 3 with no phase, and was the 10th registered.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 90 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →2 of the 11 studies testing tacrolimus in Vitiligo are open now, in 2 countries. Each count lists the studies.
Tacrolimus: first FDA approval 1994 (PROGRAF), first EMA approval 2002. What it is approved for, and how studies give it, is on its page →
Of the 48 Vitiligo studies recruiting now, 13 (27%) set no upper age limit and 29 (60%) stop at 75 or younger; 18 take children under 18; 8 take healthy volunteers.
This study: 4 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2025.
Median enrollment 51 across the 10 interventional studies. Of the 5 that completed or were terminated, 0 (0%) have results posted.
None of the 11 has an industry lead sponsor. The 10 most frequent:
Xijing Hospital is the lead sponsor of 474 studies on the registry; 159 are open to participants now.
Xijing Hospital has 6 studies filed under Vitiligo — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing tacrolimus in Vitiligo, from their registry updates:
Nothing recorded among them since 2026-09-25.
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:
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:
Outcome Measures:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Total body surface area (BSA) affected by vitiligo between 1% and 50%. Guardians provide written for the child's participation.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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).
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 weeks
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 weeks
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 weeks
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 period
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2026, 12 months after the start.
Of 63 non-industry interventional studies with no phase under Vitiligo, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 12 months is below that.
Counting every sponsor, half of 67 studies reached it within 17 months; a quarter within 8 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Tacrolimus