Vitiligo
Conditions
Keywords
JAK-inhibitor, topical, vitiligo, face, non-segmental vitiligo, delgocitinib, cream
Brief summary
This study is looking at a skin condition called vitiligo. Vitiligo is a skin condition where patches of the skin lose their natural color and become white. This study focuses specifically on vitiligo that affects the face. The treatment being tested is a cream called Anzupgo, which contains an active ingredient named delgocitinib. This cream is applied directly to the skin in the areas affected by vitiligo.The purpose of this study is to find out whether delgocitinib cream could be a helpful treatment for people who have non-segmental vitiligo on their face. During the study, participants will apply the cream to their facial vitiligo patches twice daily for a period of 24 weeks. The study will measure changes in the amount and appearance of the white patches on the face and other parts of the body after 4 weeks, 12 weeks, and 24 weeks of treatment.Throughout the study, doctors will check how well the treatment works by examining the size and severity of the vitiligo patches. They will also ask participants questions about how vitiligo affects their quality of life. The study will monitor any unwanted effects that might occur during treatment and at a follow-up visit 12 weeks after completion of the treatment period. Participants will have skin tape strips taken at the beginning of the study and during treatment to help researchers understand how the cream works on the skin.
Interventions
All patients will be treated with delgocitinib cream 20 mg/g twice daily for 24 weeks. Delgocitinib cream must be applied to the depigmented areas only on the face.
Sponsors
Lone Skov
Aage Bangs Fond
Gentofte Hospital, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, non-randomized, single-arm proof-of-concept trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Able to provide written informed consent 2. Age 18 years or above at screening 3. Ability to understand, speak, and read Danish, as assessed by the investigator 4. Have a clinical diagnosis of non-segmental vitiligo with facial involvement corresponding to at least 0.5% of total BSA 5. Agree not to use any other agent used to treat vitiligo from screening through the final visit (also please see
Exclusion criteria
9-16) 6. Able and willing to follow trial procedures including application of trial medication to facial vitiligo lesions 7. A WOCBP\* must agree to use an acceptable method of birth control\*\* throughout the trial up until the last application of the trial treatment \*A woman is defined as not being of childbearing potential if she is postmenopausal (at least 12 months with no menses without an alternative medical cause prior to screening), or surgically sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in F-VASI from baseline to Week 24 | baseline to Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change in T-VASI | Baseline, week 4, week 12, week 24 |
| Change in VETF score | Baseline, week 4, week 12, week 24 |
| Change in percentage of total and facial BSA vitiligo | Baseline, week 4, week 12, week 24 |
| Decrease of at least 50% in the F-VASI (F-VASI50) | Baseline, week 4, week 12, week 24 |
| Decrease of at least 75% in the F-VASI (F-VASI75) | Baseline, week 4, week 12, week 24 |
| Decrease of at least 90% in the F-VASI (F-VASI90) | Baseline, week 4, week 12, week 24 |
| Change in DLQI | Baseline, week 4, week 12, week 24 |
| Change in VitiQoL | Baseline, week 4, week 12, week 24 |
| Change in WHO-5 | Baseline, week 4, week 12, week 24 |
| Frequency, duration, and severity of AEs | baseline, week 4, week 12, week 24 |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORLone Skov, MD Prof
Department of Allergy, Skin and Venereal Diseases, Gentofte Hospital
Outcome results
None listed