A Phase 3 interventional study of Ruxolitinib 1.5% Cream BID in Vitiligo, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to evaluate the efficacy and safety of Ruxolitinib Phosphate Cream in treating non-segmental vitiligo in children aged 2 to 11 years under real-world conditions. The main question[s] it aims to answer are:
Primary Efficacy: What is the improvement rate (e.g., proportion of participants achieving F-VASI75) after 24 weeks of treatment with Ruxolitinib Phosphate Cream in this population? Safety Profile: What is the safety profile of the treatment over 24 weeks, specifically regarding the incidence of Application Site Acne, Application Site Pruritus, and other adverse events?
Participants will:
Apply Ruxolitinib Phosphate Cream topically to vitiligo lesions as prescribed by the investigator.
Attend scheduled clinic visits at Weeks 4, 8, 12, and 24 for efficacy and safety assessments.
Undergo standardized clinical photography and severity scoring of their vitiligo lesions at each visit.
Report any adverse events or skin reactions experienced during the study period to the research team.
This is a single-center, prospective, interventional, real-world study conducted in China. The study aims to evaluate the efficacy and safety of Ruxolitinib Phosphate Cream in the treatment of non-segmental vitiligo in children aged 2 to 11 years.
A total of eligible participants will receive topical Ruxolitinib Cream applied to vitiligo lesions as prescribed by the investigator. The treatment regimen and dosage follow the product labeling (if applicable) or standard clinical practice, with no additional randomization or blinding procedures.
The study duration is approximately 3 years, including enrollment, a 24-week treatment observation period, and follow-up. Clinical assessments are scheduled at baseline (Week 0) and at Weeks 4, 8, 12, and 24 post-treatment initiation.
Primary Outcome Measures:
- Proportion of participants achieving ≥75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) at Week 24.
Secondary Outcome Measures:
Safety Outcome Measures:
Eligibility Criteria (Key):
Data will be collected using standardized Case Report Forms (CRFs) and clinical photography. All statistical analyses will be descriptive. This real-world study will provide critical evidence on the use of Ruxolitinib Phosphate Cream in young children with non-segmental vitiligo, filling the current evidence gap in this age group.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 20 is below the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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.
In this single-arm clinical trial, all eligible subjects will receive the same investigational intervention. The study drug is Ruxolitinib Phosphate Cream, 1.5% (w/w), supplied in 100 g tubes. The dosing regimen consists of applying a thin layer of the cream to all vitiligo lesions twice daily, with approximately 12 hours between applications. Throughout the treatment period, the total application area must not exceed 10% of the Body Surface Area, and the maximum usage is limited to two tubes (totaling 200 g) per month. The entire investigational intervention will last for 24 weeks, unless a subject meets early discontinuation criteria beforehand. It must be emphasized that this drug is for cutaneous use only and is strictly prohibited for application to mucous membranes (e.g., inside the mouth, vagina) or in or around the eyes.
Drug: Ruxolitinib 1.5% Cream BID
In this single-arm clinical trial, all eligible subjects will receive the same investigational intervention. The study drug is Ruxolitinib Phosphate Cream, 1.5% (w/w), supplied in 100 g tubes. The dosing regimen consists of applying a thin layer of the cream to all vitiligo lesions twice daily, with approximately 12 hours between applications. Throughout the treatment period, the total application area must not exceed 10% of the Body Surface Area, and the maximum usage is limited to two tubes (totaling 200 g) per month. The entire investigational intervention will last for 24 weeks, unless a subject meets early discontinuation criteria beforehand. It must be emphasized that this drug is for cutaneous use only and is strictly prohibited for application to mucous membranes (e.g., inside the mouth, vagina) or in or around the eyes.
Also known as: Opzelura, ruxolitinib phosphate cream
Total-Vitiligo Area Scoring Index (T-VASI)
Improvement from baseline in the Total Vitiligo Area Scoring Index (T-VASI) at Week 24. The T-VASI ranges from 0 to 100, with higher scores indicating worse outcome (greater depigmentation).
Time frame: 24 week
Total-Vitiligo Area Scoring Index (T-VASI)
Improvement from baseline in the Total Vitiligo Area Scoring Index (T-VASI) at Week 4, 8, 12. The T-VASI ranges from 0 to 100, with higher scores indicating worse outcome (greater depigmentation).
Time frame: Weeks 4, 8, 12
Vitiligo Noticeability Scale (VNS)
Proportion of patients with Vitiligo Noticeability Scale (VNS) score of 4 or 5 at Weeks 4, 8, 12, and 24. The VNS is a patient-reported outcome measure ranging from 1 to 5, where 1 = more noticeable and 5 = no longer noticeable. Higher scores indicate better outcome. The proportion of patients achieving a score of 4 ("less noticeable") or 5 ("no longer noticeable") will be reported, including the breakdown of patients in each category.
Time frame: Weeks 4, 8, 12, 24
Total Body Surface Area (T-BSA)
Change from baseline in Total Body Surface Area (T-BSA) affected at Weeks 4, 8, 12, and 24. T-BSA is measured as the percentage of body surface area affected by vitiligo, ranging from 0% to 100%. Higher percentage indicates worse outcome.
Time frame: Weeks 4, 8, 12, 24
Children's Dermatology Life Quality Index (CDLQI)
Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at Weeks 4, 8, 12, and 24. The CDLQI is a validated pediatric dermatology quality of life questionnaire ranging from 0 to 30, where 0 = no impact on quality of life and 30 = maximum impact. Higher scores indicate worse outcome.
Time frame: Weeks 4, 8, 12, 24
Pediatric Quality of Life Inventory (PedsQL) score
Change from baseline in Pediatric Quality of Life Inventory (PedsQL) score at Weeks 4, 8, 12, and 24. The PedsQL is a generic quality of life scale ranging from 0 to 100, where 0 = worst quality of life and 100 = best quality of life. Higher scores indicate better outcome.
Time frame: Weeks 4, 8, 12, 24
Plan to share: No
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Studies of the drug tested here: Ruxolitinib
The Children's Hospital of Zhejiang University School of Medicine