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.
Vitiligo is a common chronic autoimmune skin disease characterized by skin depigmentation, resulting in white patches that can occur on any part of the body and significantly impact patients' quality of life. Currently, treatment options for vitiligo primarily include topical medications, phototherapy, systemic therapy and surgery; however, their efficacy is limited, making it difficult to achieve optimal therapeutic outcomes,with a high recurrence rate. Studies have demonstrated that the JAK-STAT signaling pathway plays a critical role in autoimmune diseases and is involved in the pathogenesis of vitiligo. The JAK inhibitor ruxolitinib cream can improve skin lesions in patients with vitiligo. This study is an investigator-initiated real-world study on the use of ruxolitinib cream for the treatment of vitiligo, with the primary objective of investigating the factors influencing the efficacy of ruxolitinib cream in vitiligo treatment. Primary outcome measure: At Week 24, the clinical characteristic differences between the groups achieving and not achieving T-VASI50 \[50% improvement of total vitiligo area scoring index (T-VASI)\]. Secondary outcome measures: (1) At Week 12 and Week 24, the proportion of patients scoring 4(slightly noticeable) or 5(no longer noticeable) on the Vitiligo Noticeability Scale (VNS), as well as the distribution of patients within each category; (2) Change from baseline in vitiligo-specific quality-of-life score (vitiligo-specific quality-of-life, VitiQoL) at Week 12 and Week 24; (3) Proportion achieving T-VASI 50/75/90 at Week 12 and Week 24; (4) Proportion achieving F-VASI 50/75/90\[facial vitiligo area scoring index(F-VASI)\] at Week 12 and Week24.
Study Type
OBSERVATIONAL
Enrollment
170
ruxolitinib twice per day
Peking University Third Hospital
Beijing, China
RECRUITINGthe 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
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
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
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
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
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