Topical Delgocitinib for Facial Vitiligo

NCT07820098 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: 2025-523635-19-002025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Keywords

JAK-inhibitor; topical; vitiligo; face; non-segmental vitiligo; delgocitinib; cream

Outcome Measures

Primary Outcomes (1)

• Change in F-VASI from baseline to Week 24

  baseline to Week 24

Secondary Outcomes (10)

• 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

Study Arms (1)

One arm open label proof of concept

EXPERIMENTAL

Drug: Delgocitinib cream

Interventions

Delgocitinib cream DRUG

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.

One arm open label proof of concept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \*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).
• \. 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

Sponsors & Collaborators

• Lone Skov: lead
• Aage Bangs Fond: collaborator
• Gentofte Hospital, Denmark: collaborator

Study Sites (1)

Department of Dermatology and Allergy Copenhagen University Hospital - Herlev and Gentofte

Gentofte Municipality, Denmark

Location

MeSH Terms

Conditions

Vitiligo; Facies

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lone Skov, MD Prof

  Department of Allergy, Skin and Venereal Diseases, Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof MD

Model Details: This is an open-label, non-randomized, single-arm proof-of-concept trial.

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 15, 2026

Record last verified: 2026-07

Locations

DK (1)