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

NCT07153666 | Recruiting DMC FDA Drug

• 1 other identifier: M20250743
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitiligo

Keywords

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

Outcome Measures

Primary Outcomes (1)

• the proportion of achieving T-VASI50 (50% improvement of total vitiligo area scoring index T-VASI)

  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.

  Week 24

Secondary Outcomes (4)

• the proportion of patients scoring 4(slightly noticeable) or 5(no longer noticeable) on the Vitiligo Noticeability Scale (VNS)

  Week 12 and Week 24

• Change from baseline in VitiQoL(vitiligo-specific quality-of-life）

  Week 12 and Week 24

• Proportion achieving T-VASI 75/90 (75/90% improvement of total vitiligo area scoring index T-VASI)

  Week 12 and Week 24

• Proportion achieving F-VASI 50/75/90(50/75/90% improvement in facial vitiligo area scoring index)

  Week 12 and Week24

Other Outcomes (1)

• Safety monitoring-proportion of acne, itching, nasopharyngitis, headache, upper respiratory tract infection, etc.

  up to Week 24

Study Arms (1)

ruxolitinib

ruxolitinib twice per day

Drug: Ruxolitinib 1.5% Cream BID

Interventions

Ruxolitinib 1.5% Cream BID DRUG

ruxolitinib twice per day

ruxolitinib

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

non-segmental vitiligo older than 12 years

You may qualify if:

• Age12 years or older, any gender;
• Signed"Informed Consent Form";
• Clinically diagnosed with non-segmental vitiligo;
• Vitiligo area less than 10% of body surface area;
• Agreed to discontinue all other vitiligo-related treatments from the screening visit until the final follow-up visit;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

MeSH Terms

Conditions

Vitiligo

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Jinzhu Guo, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinzhu Guo, MD

CONTACT

008615611963350; guojinzhu_826@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of Dermatology Department

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 4, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)