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

ConditionVitiligo
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorPeking University Third Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Allergy to ruxolitinib cream;

Pregnant or lactating women;

Any condition deemed inappropriate for study participation by the investigator.

Trial population

non-segmental vitiligo older than 12 years

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ruxolitinib 1.5% Cream BID

    Drug

    ruxolitinib twice per day

Treatment groups

170 Participants
are divided into 1 treatment group
Group A: ruxolitinib1 intervention

Trial outcomes

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.

Time frame
Week 24

Secondary outcomes

1

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

Vitiligo Noticeability Scale (VNS), a patient-reported outcome measure designed to assess the perceived change in the visibility of facial vitiligo following treatment. Patients are asked to compare the current noticeability of their vitiligo to how it appeared before treatment began. The scale offers five response options, each corresponding to a numerical score: More noticeable (score = 1) Equally noticeable (score = 2) Slightly less noticeable (score = 3) Much less noticeable (score = 4) No longer noticeable (score = 5)

Time frame
Week 12 and Week 24
2

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

Vitiligo-Specific Quality of Life Scale, a comprehensive patient-reported instrument designed to assess the impact of vitiligo on an individual's daily life and well-being over the past month.The scale consists of 16 items. The first 15 items evaluate the frequency and extent of vitiligo's influence across various domains, including emotional state (e.g., feelings of annoyance, embarrassment, depression), social interactions (e.g., worries about others' opinions, difficulty making new friends), daily activities (e.g., clothing choices, grooming, leisure activities), and overall physical health. Patients rate the frequency of each experience on a 7-point Likert scale ranging from 0 ("Not at all") to 6 ("Always"). The final item asks patients to self-assess the overall severity of their skin condition on a similar scale from 0 ("No skin problem") to 6 ("The worst possible case").

Time frame
Week 12 and Week 24
3

Proportion achieving T-VASI 75/90 (75/90% 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-VASI 75/90 score represents the proportion of subjects who achieve a≥75/90% improvement in the Vitiligo Area Scoring Index compared to baseline.

Time frame
Week 12 and Week 24
4

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

The facial Vitiligo Area Scoring Index (F-VASI) range 0 to 3, with higher scores representing a greater area of facial depigmentation across the forehead to original hairline, cheeks to jawline vertically and laterally from corner of mouth to tragus, nose, and eyelids. The F-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 F-VASI scoring formula. The specific calculation formula is: F-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 F-VASI50/75/90 score represents the proportion of subjects who achieve a≥50/75/90% improvement in the Vitiligo Area Scoring Index compared to baseline.

Time frame
Week 12 and Week24

Other outcomes

1

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

The research doctors inquired about the adverse reactions of the subjects and made records. The subjects reported their own adverse events or reactions.

Time frame
up to Week 24

Sponsors and contacts

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