Nonsegmental vitiligo with genital involvement
Conditions
Brief summary
The primary endpoint is the proportion of participants achieving a genital VNS of "4 – A lot less noticeable" or "5 – No longer noticeable" at Week 48.
Detailed description
Occurrence of AEs and changes in vital signs and laboratory data., Proportion of participants achieving genital PhGVA of 0 or 1 at Week 48., Change from baseline in affected BSA in the genital region at Weeks 24 and 48., Proportion of participants achieving T-VASI50/75/90 at Weeks 24 and 48., Proportion of participants achieving a genital VNS of "4 – A lot less noticeable" or "5 – No longer noticeable" at Week 24., Proportion of participants in each category of the color-matching question at Weeks 24 and 48.
Interventions
DRUGRuxolitinib cream
Sponsors
Incyte Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of participants achieving a genital VNS of "4 – A lot less noticeable" or "5 – No longer noticeable" at Week 48. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of AEs and changes in vital signs and laboratory data., Proportion of participants achieving genital PhGVA of 0 or 1 at Week 48., Change from baseline in affected BSA in the genital region at Weeks 24 and 48., Proportion of participants achieving T-VASI50/75/90 at Weeks 24 and 48., Proportion of participants achieving a genital VNS of "4 – A lot less noticeable" or "5 – No longer noticeable" at Week 24., Proportion of participants in each category of the color-matching question at Weeks 24 and 48. | — |
Countries
France
Outcome results
None listed