VitiligoPhase 3NCT07595939
Efficacy and Safety of Ruxolitinib Cream in Chinese Children Aged 2-11 Years With Non-segmental Vitiligo
A Phase 3 study testing Ruxolitinib 1.5% Cream BID in people with Vitiligo, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- Ruxolitinib 1.5% Cream BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 11 years, regardless of sex.
- Clinical diagnosis of non-segmental vitiligo, with affected Body Surface Area (BSA) ≥0.1%, T-VASI score ≥0.1, and total depigmented area not exceeding 10% BSA.
- Legal guardian voluntarily provides signed informed consent and agrees to scheduled follow-ups.
Who cannot join
- Diagnosis of other forms of vitiligo (e.g., segmental vitiligo).
- Presence of other hypopigmentary or depigmentary disorders that could interfere with efficacy assessment (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus depigmentosus, and tinea versicolor).
- Prior or current use of any treatment for depigmentation.
- History of failure with any systemic or topical JAK inhibitor therapy for vitiligo or any other inflammatory condition.
- Known hypersensitivity to the study drug or its excipients.
- Concurrent participation in another clinical trial.
- Considered by the investigator to be unsuitable for the study for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Yunqing Ren, 0571-86670281, yqren@zju.edu.cn
Yunqing Ren
About this study
Official title: Efficacy and Safety of Ruxolitinib Cream in Children Aged 2-11 Years With Non-segmental Vitiligo: A Single-Center, Real-World Study
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?
Read more
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.
Read the detailed description
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:
- Proportion of participants achieving F-VASI50, F-VASI90, and Total Vitiligo Area Scoring Index (T-VASI50, T-VASI75) at Weeks 4, 8, 12, and 24.
- Change from baseline in quality of life assessed by the Children's Dermatology Life Quality Index (CDLQI) or appropriate pediatric dermatology quality of life scale.
- Proportion of participants with ≥50% improvement in T-VASI (T-VASI50) at Week 24.
Safety Outcome Measures:
- Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) throughout the study period, with special attention to application site acne, application site pruritus, and other local skin reactions.
- Proportion of participants discontinuing treatment or withdrawing from the study due to AEs.
Eligibility Criteria (Key):
- Inclusion: Children aged 2-11 years, clinically diagnosed with non-segmental vitiligo, with depigmented BSA ≥0.1% and T-VASI ≥0.1, total body depigmentation area ≤10% BSA. Legal guardian provides signed informed consent.
- Exclusion: Diagnosis of segmental or other types of vitiligo; other depigmentation disorders; prior use of depigmenting treatments; history of JAK inhibitor failure; allergy to study drug; participation in another clinical trial; judged unsuitable by investigator.
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.
- Conditions
- Vitiligo
- Being tested
- Ruxolitinib 1.5% Cream BID
- Keywords
- vitiligo, Ruxolitinib, children
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 1.5% Cream BIDDrug
Also called Opzelura, ruxolitinib phosphate cream
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.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib treatment | Experimental | 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. Receives: Drug: Ruxolitinib 1.5% Cream BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 week
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 4, 8, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunqing Ren, PhD, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595939
- Sponsor's protocol ID
- 2026-IEC-0016
- Status last verified
- Dec 2025
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ruxolitinib Cream in Children Aged 2-11 Years With Non-segmental Vitiligo: A Single-Center, Real-World Study
- ClinicalTrials.gov ID
- NCT07595939
- Acronym / sponsor ID
- 2026-IEC-0016
- Conditions
- Vitiligo
- Keywords
- vitiligo, Ruxolitinib, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Proportion of participants achieving F-VASI50, F-VASI90, and Total Vitiligo Area Scoring Index (T-VASI50, T-VASI75) at Weeks 4, 8, 12, and 24.
- Change from baseline in quality of life assessed by the Children's Dermatology Life Quality Index (CDLQI) or appropriate pediatric dermatology quality of life scale.
- Proportion of participants with ≥50% improvement in T-VASI (T-VASI50) at Week 24.
Safety Outcome Measures:
- Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) throughout the study period, with special attention to application site acne, application site pruritus, and other local skin reactions.
- Proportion of participants discontinuing treatment or withdrawing from the study due to AEs.
Eligibility Criteria (Key):
- Inclusion: Children aged 2-11 years, clinically diagnosed with non-segmental vitiligo, with depigmented BSA ≥0.1% and T-VASI ≥0.1, total body depigmentation area ≤10% BSA. Legal guardian provides signed informed consent.
- Exclusion: Diagnosis of segmental or other types of vitiligo; other depigmentation disorders; prior use of depigmenting treatments; history of JAK inhibitor failure; allergy to study drug; participation in another clinical trial; judged unsuitable by investigator.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib treatment | Experimental | Drug: Ruxolitinib 1.5% Cream BIDIn 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. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2 to 11 years, regardless of sex.
- Clinical diagnosis of non-segmental vitiligo, with affected Body Surface Area (BSA) ≥0.1%, T-VASI score ≥0.1, and total depigmented area not exceeding 10% BSA.
- Legal guardian voluntarily provides signed informed consent and agrees to scheduled follow-ups.
Key exclusion criteria (7 listed)
- Diagnosis of other forms of vitiligo (e.g., segmental vitiligo).
- Presence of other hypopigmentary or depigmentary disorders that could interfere with efficacy assessment (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus depigmentosus, and tinea versicolor).
- Prior or current use of any treatment for depigmentation.
- History of failure with any systemic or topical JAK inhibitor therapy for vitiligo or any other inflammatory condition.
- Known hypersensitivity to the study drug or its excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib 1.5% Cream BIDAlso: Opzelura, ruxolitinib phosphate creamIn 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 treatment |
Primary outcome
Total-Vitiligo Area Scoring Index (T-VASI)
Time frame: 24 week
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).
5 secondary outcomes
Total-Vitiligo Area Scoring Index (T-VASI)
Time frame: Weeks 4, 8, 12
Vitiligo Noticeability Scale (VNS)
Time frame: Weeks 4, 8, 12, 24
Total Body Surface Area (T-BSA)
Time frame: Weeks 4, 8, 12, 24
Children's Dermatology Life Quality Index (CDLQI)
Time frame: Weeks 4, 8, 12, 24
Pediatric Quality of Life Inventory (PedsQL) score
Time frame: Weeks 4, 8, 12, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yunqing Ren, PhD principal investigator
The Children's Hospital of Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ruxolitinib 1.5% Cream BID in people with Vitiligo, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunqing Ren, PhD (0571-86670281, yqren@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total-Vitiligo Area Scoring Index (T-VASI) (time frame: 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.