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.
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
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 group | Role | What they receive |
|---|---|---|
| One arm open label proof of concept | Experimental | Not described Receives: Drug: Delgocitinib cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in F-VASI from baseline to Week 24
Measured: baseline to Week 24
Secondary outcomes (10)
Change in T-VASI
Measured: Baseline, week 4, week 12, week 24
Change in VETF score
Measured: Baseline, week 4, week 12, week 24
Change in percentage of total and facial BSA vitiligo
Measured: Baseline, week 4, week 12, week 24
Decrease of at least 50% in the F-VASI (F-VASI50)
Measured: Baseline, week 4, week 12, week 24
Decrease of at least 75% in the F-VASI (F-VASI75)
Measured: Baseline, week 4, week 12, week 24
Decrease of at least 90% in the F-VASI (F-VASI90)
Measured: Baseline, week 4, week 12, week 24
Change in DLQI
Measured: Baseline, week 4, week 12, week 24
Change in VitiQoL
Measured: Baseline, week 4, week 12, week 24
Change in WHO-5
Measured: Baseline, week 4, week 12, week 24
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.
- First posted15 Sep 2026
- Study start8 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lone Skov
- Sponsor type
- University, hospital or other
- Collaborators
- Aage Bangs Fond, Gentofte Hospital, Denmark
- Responsible party
- Sponsor-investigator, Lone Skov, Gentofte Hospital
- Investigators
- Lone Skov, MD Prof, Principal investigator, Department of Allergy, Skin and Venereal Diseases, Gentofte Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Proof-of-concept Trial of Topical Delgocitinib in Patients With Facial Vitiligo
- ClinicalTrials.gov ID
- NCT07820098
- Acronym / sponsor ID
- DelVito / 2025-523635-19-00
- Conditions
- Vitiligo
- Keywords
- JAK-inhibitor, topical, vitiligo, face, non-segmental vitiligo, delgocitinib, cream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lone SkovUniversity, hospital or other
- Collaborators
- Aage Bangs Fond, Gentofte Hospital, Denmark
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, non-randomized, single-arm proof-of-concept trial.
| Arm | Type | Receives |
|---|---|---|
| One arm open label proof of concept | Experimental | Drug: Delgocitinib cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delgocitinib creamAll 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. | Drug | One arm open label proof of concept |
Primary outcome
Change in F-VASI from baseline to Week 24
Time frame: baseline to Week 24
10 secondary outcomes
Change in T-VASI
Time frame: Baseline, week 4, week 12, week 24
Change in VETF score
Time frame: Baseline, week 4, week 12, week 24
Change in percentage of total and facial BSA vitiligo
Time frame: Baseline, week 4, week 12, week 24
Decrease of at least 50% in the F-VASI (F-VASI50)
Time frame: Baseline, week 4, week 12, week 24
Decrease of at least 75% in the F-VASI (F-VASI75)
Time frame: Baseline, week 4, week 12, week 24
Decrease of at least 90% in the F-VASI (F-VASI90)
Time frame: Baseline, week 4, week 12, week 24
Change in DLQI
Time frame: Baseline, week 4, week 12, week 24
Change in VitiQoL
Time frame: Baseline, week 4, week 12, week 24
Change in WHO-5
Time frame: Baseline, week 4, week 12, week 24
Frequency, duration, and severity of AEs
Time frame: baseline, week 4, week 12, week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Vitiligo
RecruitingPhase 2
A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
Non-Segmental Vitiligo (NSV)
Active, not recruitingPhase 1
A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
Vitiligo
Active, not recruitingPhase 3
A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2
Stable Nonsegmental Vitiligo, Active Nonsegmental Vitiligo
RecruitingPhase 2
A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo
Non-segmental Vitiligo
RecruitingPhase 1
A Trial to Test the Safety and Efficacy of TEV-53408 in Participants With Vitiligo
Vitiligo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lone Skov, MD Prof principal investigator
Department of Allergy, Skin and Venereal Diseases, Gentofte Hospital
1 site in 1 country: see every site and its status.
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.