Efficacy and Safety of Ruxolitinib Cream in Chinese Children Aged 2-11 Years With Non-segmental Vitiligo

NCT07595939 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 2026-IEC-0016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vitiligo

Keywords

vitiligo; Ruxolitinib; children

Outcome Measures

Primary Outcomes (1)

• 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).

  24 week

Secondary Outcomes (5)

• Total-Vitiligo Area Scoring Index (T-VASI)

  Weeks 4, 8, 12

• Vitiligo Noticeability Scale (VNS)

  Weeks 4, 8, 12, 24

• Total Body Surface Area (T-BSA)

  Weeks 4, 8, 12, 24

• Children's Dermatology Life Quality Index (CDLQI)

  Weeks 4, 8, 12, 24

• Pediatric Quality of Life Inventory (PedsQL) score

  Weeks 4, 8, 12, 24

Study Arms (1)

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.

Drug: Ruxolitinib 1.5% Cream BID

Interventions

Ruxolitinib 1.5% Cream BID DRUG

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

Ruxolitinib treatment

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

MeSH Terms

Conditions

Vitiligo

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yunqing Ren, PhD

  The Children's Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunqing Ren, PhD

CONTACT

0571-86670281; yqren@zju.edu.cn

Jipeng Liu, PhD

CONTACT

0571-86670281; liujipeng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 19, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)