Open-label proof-of-concept trial of topical delgocitinib in patients with facial vitiligo

Conditions

Vitiligo

Brief summary

Change in F-VASI from baseline to Week 24

Detailed description

Change in T-VASI from baseline to Week 24, Change in VESplus from baseline to Week 24, Change in VETF score from baseline to Week 24, Change in facial BSA from baseline to Week 24, Change in total BSA from baseline to Week 24, F-VASI50 at Week 24, F-VASI75 at Week 24, F-VASI90 at Week 24, Change in T-VASI at Weeks 4 and 12, Change in VESplus at Weeks 4 and 12, Change in VETF score at Weeks 4 and 12, F-VASI50 at Weeks 4 and 12, F-VASI75 at Weeks 4 and 12, F-VASI90 at Weeks 4 and 12, Change in DQOL from baseline to Week 24, Change in VitiQoL from baseline to Week 24, Change in WHO-5 from baseline to Week 24, Change in DQOL at Weeks 4 and 12, Change in VitiQoL at Weeks 4 and 12, Change in WHO-5 at Weeks 4 and 12, Frequency, duration, and severity of AEs, Changes in skin proteome and transcriptome from baseline to Weeks 4 and 24 (analyses will be performed if a change in F-VASI is shown)

Related papers

No related papers found yet.

Interventions

DRUGAnzupgo 20 mg/g cream

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in F-VASI from baseline to Week 24	—

Secondary

Measure	Time frame
Change in T-VASI from baseline to Week 24, Change in VESplus from baseline to Week 24, Change in VETF score from baseline to Week 24, Change in facial BSA from baseline to Week 24, Change in total BSA from baseline to Week 24, F-VASI50 at Week 24, F-VASI75 at Week 24, F-VASI90 at Week 24, Change in T-VASI at Weeks 4 and 12, Change in VESplus at Weeks 4 and 12, Change in VETF score at Weeks 4 and 12, F-VASI50 at Weeks 4 and 12, F-VASI75 at Weeks 4 and 12, F-VASI90 at Weeks 4 and 12, Change in DQOL from baseline to Week 24, Change in VitiQoL from baseline to Week 24, Change in WHO-5 from baseline to Week 24, Change in DQOL at Weeks 4 and 12, Change in VitiQoL at Weeks 4 and 12, Change in WHO-5 at Weeks 4 and 12, Frequency, duration, and severity of AEs, Changes in skin proteome and transcriptome from baseline to Weeks 4 and 24 (analyses will be performed if a change in F-VASI is shown)	—

Measure

Time frame

Change in T-VASI from baseline to Week 24, Change in VESplus from baseline to Week 24, Change in VETF score from baseline to Week 24, Change in facial BSA from baseline to Week 24, Change in total BSA from baseline to Week 24, F-VASI50 at Week 24, F-VASI75 at Week 24, F-VASI90 at Week 24, Change in T-VASI at Weeks 4 and 12, Change in VESplus at Weeks 4 and 12, Change in VETF score at Weeks 4 and 12, F-VASI50 at Weeks 4 and 12, F-VASI75 at Weeks 4 and 12, F-VASI90 at Weeks 4 and 12, Change in DQOL from baseline to Week 24, Change in VitiQoL from baseline to Week 24, Change in WHO-5 from baseline to Week 24, Change in DQOL at Weeks 4 and 12, Change in VitiQoL at Weeks 4 and 12, Change in WHO-5 at Weeks 4 and 12, Frequency, duration, and severity of AEs, Changes in skin proteome and transcriptome from baseline to Weeks 4 and 24 (analyses will be performed if a change in F-VASI is shown)

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Countries

Denmark

Outcome results

None listed