Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-29 @ 11:00 AM
Study NCT ID:
NCT07153666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-world Study on the Influencing Factors of Efficacy of Ruxolitinib Cream in Vitiligo
Sponsor:
Peking University Third Hospital
Organization:
Study Overview
Official Title:
A Real-world Study on the Influencing Factors of the Efficacy of Ruxolitinib Cream in the Treatment of Vitiligo
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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.
(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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: