Factors influencing how well ruxolitinib cream works in vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University Third Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: Jinzhu Guo, MD — Peking University Third Hospital
• Study coordinator: Jinzhu Guo, MD
• Email: guojinzhu_826@163.com
• Phone: 008615611963350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.