AzTrials
AzTrials

VitiligoPhase 2DelVitoNCT07820098

Topical Delgocitinib for Facial Vitiligo

A Phase 2 study testing Delgocitinib cream in people with Vitiligo, run by Lone Skov at 1 site in Denmark.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vitiligo
What is being tested?
Delgocitinib cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteDenmark
Study dates
8 Apr 2026to Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 1. 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Department of Dermatology and Allergy Copenhagen University Hospital - Herlev and Gentofte

    Gentofte Municipality

Other trials in Denmark

About this study

Official title: Open-label Proof-of-concept Trial of Topical Delgocitinib in Patients With Facial Vitiligo

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
Being tested
Delgocitinib cream
Keywords
JAK-inhibitor, topical, vitiligo, face, non-segmental vitiligo, delgocitinib, cream
Medical subject headings
Vitiligo, Facies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delgocitinib creamDrug

    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.

Study groups in NCT07820098
Study groupRoleWhat they receive
One arm open label proof of conceptExperimentalNot described
Receives: Drug: Delgocitinib cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in F-VASI from baseline to Week 24

    Measured: baseline to Week 24

Secondary outcomes (10)
  1. Change in T-VASI

    Measured: Baseline, week 4, week 12, week 24

  2. Change in VETF score

    Measured: Baseline, week 4, week 12, week 24

  3. Change in percentage of total and facial BSA vitiligo

    Measured: Baseline, week 4, week 12, week 24

  4. Decrease of at least 50% in the F-VASI (F-VASI50)

    Measured: Baseline, week 4, week 12, week 24

  5. Decrease of at least 75% in the F-VASI (F-VASI75)

    Measured: Baseline, week 4, week 12, week 24

  6. Decrease of at least 90% in the F-VASI (F-VASI90)

    Measured: Baseline, week 4, week 12, week 24

  7. Change in DLQI

    Measured: Baseline, week 4, week 12, week 24

  8. Change in VitiQoL

    Measured: Baseline, week 4, week 12, week 24

  9. Change in WHO-5

    Measured: Baseline, week 4, week 12, week 24

  10. Frequency, duration, and severity of AEs

    Measured: baseline, week 4, week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2026
  2. Study start8 Apr 2026
  3. Primary completionApr 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label, non-randomized, single-arm proof-of-concept trial.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07820098
Sponsor's protocol ID
2025-523635-19-00
Other IDs
2025
Acronym
DelVito
Status last verified
Jul 2026
First submitted
9 Sep 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Delgocitinib cream in people with Vitiligo, run by Lone Skov at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in F-VASI from baseline to Week 24 (time frame: baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in