Topical Delgocitinib for Facial Vitiligo

Inclusion criteria

• 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).

Exclusion criteria

• Disease duration of more than 10 years in the area chosen for treatment 2. Signs of follicular repigmentation in the area chosen for treatment 3. Concurrent skin diseases in the face 4. Other active skin diseases requiring medical treatment 5. Other forms of vitiligo (e.g., segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders (e.g., piebaldism, pityriasis alba, leprosy, post inflammatory hypopigmentation, progressive macule hypomelanosis, idiopathic guttate hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor) 6. Patients who have no pigmented hair within any of the vitiligo areas on the face 7. Clinically significant bacterial, viral, or fungal skin infection in the face within one week before baseline 8. Known or suspected hypersensitivity to any components of the trial drug 9. Previous or current treatment with JAK inhibitors (including delgocitinib), systemic or topical 10. Treatment with any marketed biological therapy or investigational biologic agents within 12 weeks or 5-lives, whichever is longer, prior to baseline 11. Systemic treatment with immunosuppressive or immunomodulating drugs within 12 weeks prior to baseline 12. Use of tanning beds, phototherapy, or intentional UV exposure within 12 weeks prior to baseline 13. Cutaneous applied treatment with topical corticosteroids or other immunomodulators such as phosphodiesterase type 4 inhibitors or calcineurin inhibitors within four weeks prior to baseline 14. Any systemic or topical therapies that could increase the skin sensitivity to UV/visible light or impact skin pigmentation, that is, retinoids, tetracyclines within four weeks prior to baseline 15. Any depigmentation treatments for past treatment of vitiligo or other pigmented areas 16. Surgical or laser treatments in the facial area within 12 weeks prior to baseline 17. History of any known primary immunodeficiency disorder 18. Planned hospitalization during the trial period 19. History of cancer (for skin cancer in the facial area, the patient is NOT eligible; for skin cancer outside of the facial area, a patient is eligible if in remission and curative therapy has been completed ≥12 months prior to screening; for other malignancies, a patient is eligible if in remission and curative therapy has been completed ≥5 years prior to screening) 20. Any unstable disorder that could affect the safety of the patient throughout the trial or impede the patient's ability to complete the trial 21. Any clinically abnormal finding observed during the screening period that could affect the safety of the patient or influence the ability to complete the trial 22. Any significant illness or medical, physical, or psychiatric condition that, in the opinion of the investigator, could hinder the participant's ability to fully engage in the study-such as receiving the trial medication or attending scheduled visits-pose a notable risk to their health, or compromise the integrity of the trial data 23. Current participation in any other interventional clinical trial 24. Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator 25. Women who are pregnant or breastfeeding, or women considering pregnancy during the period of their trial participation