Ruxolitinib 1.5% Cream BID: ruxolitinib twice per day
Study summary
Vitiligo is a common chronic autoimmune skin disease that can occur on any part of the body and severely impacts patients' quality of life. Current treatment for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgical interventions, but their efficacy is limited, often failing to achieve ideal therapeutic outcomes, and are associated with a high recurrence rate. This study is an investigator-initiated real-world research on the application of ruxolitinib cream for vitiligo treatment, with the primary objective of exploring the factors influencing the efficacy of ruxolitinib cream in treating vitiligo.
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
the proportion of achieving T-VASI50 (50% improvement of total vitiligo area scoring index T-VASI) — Week 24 First, determine the body parts to be evaluated, including the face and neck, palms, upper limbs, trunk, lower limbs and feet, five regions in total. Using the patient's palm as 1% of body surface area to estimate the area of depigmented patches in each body part, measuring the area of depigmented patches within each region. The T-VASI score categorizes the degree of depigmentation into seven levels: 0%, 10%,25%,50%,75%,90%, or 100%. Based on the area of depigmented patches and the degree of depigmentation in each region, the score for each region is calculated according to the T-VASI scoring formula. The specific calculation formula is:T-VASI=∑(number of handprint units occupied by each body part)× the percentage of pigment loss in that region. The score ranges from 0 to 100. The T-VASI50 score represents the proportion of subjects who achieve a≥50% improvement in the Vitiligo Area Scoring Index compared to baseline.
Trial sites (1)
Facility
City
Region
Status
Peking University Third Hospital
Beijing
China
Recruiting
More Peking University Third Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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