Factors influencing how well ruxolitinib cream works in vitiligo

A Real-world Study on the Influencing Factors of the Efficacy of Ruxolitinib Cream in the Treatment of Vitiligo

This study tests whether patient and disease characteristics affect how well ruxolitinib 1.5% cream works for people aged 12 and older with non‑segmental vitiligo covering under 10% of the body.

Quick facts

• Study type: Observational
• Enrollment: 170 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Drugs / interventions: ruxolitinib
• Locations: 1 site (Beijing)
• Trial ID: NCT07153666 on ClinicalTrials.gov

What this trial studies

This investigator‑initiated, real‑world observational study at Peking University Third Hospital follows patients with non‑segmental vitiligo using ruxolitinib 1.5% cream twice daily. Participants aged 12 and older with less than 10% body surface area involvement discontinue other vitiligo therapies and are followed through at least 24 weeks. The primary endpoint compares clinical characteristics between patients who do and do not achieve a 50% improvement in total vitiligo area scoring index (T‑VASI50) at Week 24, and secondary endpoints include Vitiligo Noticeability Scale scores and vitiligo‑specific quality‑of‑life changes at Weeks 12 and 24. Collected real‑world data will be analyzed to identify factors that correlate with treatment response in routine clinical practice.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12 or older with non‑segmental vitiligo affecting less than 10% of body surface area who can stop other vitiligo treatments and attend follow‑up visits.

Not a fit: Patients with segmental vitiligo, more extensive disease (>10% BSA), those planning pregnancy or unable to stop other therapies, or those unwilling to attend in‑person visits are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the results could help clinicians predict which patients are most likely to achieve meaningful repigmentation with ruxolitinib cream.

How similar studies have performed: Randomized trials and open‑label studies of topical ruxolitinib and other JAK inhibitors have shown repigmentation benefit, so this real‑world study builds on existing evidence.

Eligibility criteria

Inclusion Criteria:

1. Age12 years or older, any gender;
2. Signed"Informed Consent Form";
3. Clinically diagnosed with non-segmental vitiligo;
4. Vitiligo area less than 10% of body surface area;
5. Agreed to discontinue all other vitiligo-related treatments from the screening visit until the final follow-up visit;
6. Female subjects must not plan for pregnancy or oocyte donation from screening until 4 weeks after the last dose and must voluntarily adopt highly effective physical contraception; male subjects must not plan for fertility or sperm donation during the same period and must voluntarily adopt highly effective physical contraception. Methods include:

   * Barrier methods: Condom or barrier cap (diaphragm or cervical cap);
   * Intrauterine device (IUD) or intrauterine system (IUS);
   * Surgical sterilization (bilateral oophorectomy with/without hysterectomy, total hysterectomy, bilateral tubal ligation, or vasectomy) performed ≥6 months prior to the first dose in the subject or their partner;
   * Other investigator-confirmed highly effective physical contraception.

Exclusion Criteria:

1. Allergy to ruxolitinib cream;
2. Pregnant or lactating women;
3. Any condition deemed inappropriate for study participation by the investigator.

Where this trial is running

Beijing

• Peking University Third Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Jinzhu Guo, MD — Peking University Third Hospital
• Study coordinator: Jinzhu Guo, MD

Conditions Vitiligo; vitiligo; JAK; ruxolitinib; treatment; efficacy; influencing factors