VitiligoERASENCT04843059
ERASE VITILIGO Early Repigmentation Approach for Stopping the Evolution of VITILIGO Prospective Multicentric Interventional Study With Blinded Evaluation
A study testing The resident memory T-cell infiltrate in perilesional vitiligo skin in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
Vitiligo affects 1 to 2% of worldwide population and has a demonstrated impact on the quality of life. Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), in particular T cells, but also to induce the differentiation of melanocyte stem cells (to… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Vitiligo
- What is being tested?
- The resident memory T-cell infiltrate in perilesional vitiligo skin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2021to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Patients with non-segmental vitiligo. 3 groups of patients will be selected:
- Patients with a long-lasting disease (more than 2 years) and no new or growing lesion since at least 2 years
- Patients with a long-lasting disease (more than 2 years) and with at least one new lesion since less than 6 months
- Patients developing for the first-time vitiligo lesions with all the lesions no older than 6 months 2. ≥ 18 and <35 years to have a homogeneous distribution of age between the three groups, as 80% of vitiligo cases start before the age of 30.
- 3. Patient with at least one lesion of more than 2 cm² not located on the face, hands or feet.
- 4. Patient needing a treatment with oral minipulses of steroids and phototherapy 5. For women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed.
- 6. Affiliation to a social security system 7. Signed informed consent
Who cannot join
- 1. Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration.
- 2. Segmental or mixed vitiligo 3. Vitiligo located only on face, hands and feet 4. Exposure to solar or artificial UV during the months before inclusion 5. Concomitant use of topical or systemic immunosuppressive medication or steroids 6. Patients suffering from photodermatosis or taking photosensitive drugs 7. Personal history of skin cancer. 8. Patients with diabetes, high blood pressure, osteoporosis or any other contra-indication to the use of systemic steroids.
- 9. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or deprived of freedom 10. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Bordeaux
Bordeaux, 33440
CHU de Nice
Nice, alpes maritimes, 06001
About this study
Vitiligo affects 1 to 2% of worldwide population and has a demonstrated impact on the quality of life.
Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), in particular T cells, but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). Ultimately, the treatment should also prevent the recurrences of depigmentation. Indeed, when repigmentation is achieved, 40 to 50% of lesions reoccur within one year, suggesting that skin resident memory T cell clones remain in repigmented vitiligo skin and might explain these recurrences.
Read more
The investigators hypothesize that a very early intervention could prevent the accumulation of the skin resident memory T cells in vitiligo lesions. Moreover, they also think that such an early treatment would also optimize the repigmentation process, even in traditionally resistant areas, as some remaining pre-melanocytes and maybe even some melanocytes, could proliferate and recolonize the epidermis.
Objectives : to compare the resident memory T-cell infiltrate in perilesional vitiligo skin after 6 months of treatment with OMP and UVB, between three groups of patients suffering from non-segmental vitiligo Interventions The 3 groups will receive a combination of narrowband UVB (Nb-UVB) 3 times a week and oral mini pulses of systemic steroids (5 mg of d medrol 16mg twice a week) for 24 weeks.
Three visits will be done (inclusion, Week 12 and 24) A skin biopsy will be done on lesional and peri-lesional area at baseline. Another skin biopsy will be taken after 24 weeks but only in perilesional area. A blood sample for assessing the circulating memory T cells and for checking the tolerance will be performed at baseline, then at W12 and W24.
The combination of narrowband UVB and oral minipulse of steroids are considered as a standard care of active vitiligo patients. Clinical assessment (including blood pressure) and hemogram, liver enzymes, urea, creatinemia, glycemia, natremia and kaliema will be assessed at baseline, 3 and 6 months.
Main criteria of evaluation:
The target lesion will be chosen before any treatment. The minimal size will be 2cm². Considering that skin on the face usually responds very well whilst that of hands and feet respond poorly, to avoid potential bias due to the location of treatment, these locations won't be taken as target lesions. In any cases, no biopsy will be taken on the face or in the folds.
- Conditions
- Vitiligo
- Being tested
- The resident memory T-cell infiltrate in perilesional vitiligo skin
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The resident memory T-cell infiltrate in perilesional vitiligo skinOther
The 3 groups will receive a combination of narrowband UVB (Nb-UVB) 3 times a week and oral mini pulses of systemic steroids (5 mg of d medrol 16mg twice a week) for 24 weeks.
Three visits will be done (inclusion, Week 12 and 24) A skin biopsy will be done on lesional and peri-lesional area at baseline. Another skin biopsy will be taken after 24 weeks but only in perilesional area. A blood sample for assessing the circulating memory T cells and for checking the tolerance will be performed at baseline, then at W12 and W24.
| Study group | Role | What they receive |
|---|---|---|
| the resident memory T-cell infiltrate in perilesional vitiligo skin | Other | To compare the resident memory T-cell infiltrate in perilesional vitiligo skin after 6 months of treatment with OMP and UVB, between three groups of patients suffering from non-segmental vitiligo, using flow cytometric analysis.
* First group will include patients with a long-lasting disease (more than 2 years) and no new or growing lesions for at least 2 years: Old vitiligo with Old lesions
* The second group will include patients with a long-lasting disease (more than 2 years) and with at least one new lesion developed in the last 6 months: Old vitiligo with new lesions
* The third one will include patients developing, for the first-time, vitiligo lesions with all the lesions no older than 6 months: New vitiligo Receives: Other: The resident memory T-cell infiltrate in perilesional vitiligo skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of resident memory T-cells (ratio memory T cells (CD4+CD69++ and CD8+CD69+)/Total CD4+ and CD8+ *100), assessed by cytometric analysis, in the perilesional skin of the target lesion.
The target lesion will be chosen before any treatment. The minimal size will be 2cm². Considering that skin on the face usually responds very well whilst that of hands and feet respond poorly, to avoid potential bias due to the location of treatment, these locations won't be taken as target lesions. In any cases, no biopsy will be taken on the face or in the folds.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Jun 2021
- Primary completion10 Oct 2024
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To compare the resident memory T-cell infiltrate in perilesional vitiligo skin after 6 months of treatment with OMP and UVB, between three groups of patients suffering from non-segmental vitiligo, using flow cytometric analysis. * First group will include patients with a long-lasting disease (more than 2 years) and no new or growing lesions for at least 2 years: Old vitiligo with Old lesions * The second group will include patients with a long-lasting disease (more than 2 years) and with at least one new lesion developed in the last 6 months: Old vitiligo with new lesions * The third one will include patients developing, for the first-time, vitiligo lesions with all the lesions no older than 6 months: New vitiligo
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Passeron Thierry, PhD, Principal investigator, CHU de Nice, Service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843059
- Sponsor's protocol ID
- 21-PP-01
- Acronym
- ERASE
- Status last verified
- Aug 2025
- First submitted
- 8 Apr 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marin Dit Bertoud Q, Bertold C, Ezzedine K, Pandya AG, Cherel M, Castillo Martinez A, Seguy MA, Abdallah M, Bae JM, Bohm M, Parsad D, Rosmarin D, Wolkerstorfer A, Bahadoran P, Blaise M, Dugourd PM, Philippo V, Delaval JM, Passeron T. Reliability and agreement testing of a new automated measurement method to determine facial vitiligo extent using standardized ultraviolet images and a dedicated algorithm. Br J Dermatol. 2023 Dec 20;190(1):62-69. doi: 10.1093/bjd/ljad304.
PubMed 37615581
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERASE VITILIGO Early Repigmentation Approach for Stopping the Evolution of VITILIGO Prospective Multicentric Interventional Study With Blinded Evaluation
- ClinicalTrials.gov ID
- NCT04843059
- Acronym / sponsor ID
- ERASE / 21-PP-01
- Conditions
- Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 13 Apr 2021 (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.
Vitiligo affects 1 to 2% of worldwide population and has a demonstrated impact on the quality of life.
Optimal treatment of vitiligo requires to target the auto-immune inflammatory response (to halt the depigmentation process), in particular T cells, but also to induce the differentiation of melanocyte stem cells (to induce repigmentation). Ultimately, the treatment should also prevent the recurrences of depigmentation. Indeed, when repigmentation is achieved, 40 to 50% of lesions reoccur within one year, suggesting that skin resident memory T cell clones remain in repigmented vitiligo skin and might explain these recurrences.
The investigators hypothesize that a very early intervention could prevent the accumulation of the skin resident memory T cells in vitiligo lesions. Moreover, they also think that such an early treatment would also optimize the repigmentation process, even in traditionally resistant areas, as some remaining pre-melanocytes and maybe even some melanocytes, could proliferate and recolonize the epidermis.
Objectives : to compare the resident memory T-cell infiltrate in perilesional vitiligo skin after 6 months of treatment with OMP and UVB, between three groups of patients suffering from non-segmental vitiligo Interventions The 3 groups will receive a combination of narrowband UVB (Nb-UVB) 3 times a week and oral mini pulses of systemic steroids (5 mg of d medrol 16mg twice a week) for 24 weeks.
Three visits will be done (inclusion, Week 12 and 24) A skin biopsy will be done on lesional and peri-lesional area at baseline. Another skin biopsy will be taken after 24 weeks but only in perilesional area. A blood sample for assessing the circulating memory T cells and for checking the tolerance will be performed at baseline, then at W12 and W24.
The combination of narrowband UVB and oral minipulse of steroids are considered as a standard care of active vitiligo patients. Clinical assessment (including blood pressure) and hemogram, liver enzymes, urea, creatinemia, glycemia, natremia and kaliema will be assessed at baseline, 3 and 6 months.
Main criteria of evaluation:
The target lesion will be chosen before any treatment. The minimal size will be 2cm². Considering that skin on the face usually responds very well whilst that of hands and feet respond poorly, to avoid potential bias due to the location of treatment, these locations won't be taken as target lesions. In any cases, no biopsy will be taken on the face or in the folds.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To compare the resident memory T-cell infiltrate in perilesional vitiligo skin after 6 months of treatment with OMP and UVB, between three groups of patients suffering from non-segmental vitiligo, using flow cytometric analysis. * First group will include patients with a long-lasting disease (more than 2 years) and no new or growing lesions for at least 2 years: Old vitiligo with Old lesions * The second group will include patients with a long-lasting disease (more than 2 years) and with at least one new lesion developed in the last 6 months: Old vitiligo with new lesions * The third one will include patients developing, for the first-time, vitiligo lesions with all the lesions no older than 6 months: New vitiligo
| Arm | Type | Receives |
|---|---|---|
| the resident memory T-cell infiltrate in perilesional vitiligo skin | Other | Other: The resident memory T-cell infiltrate in perilesional vitiligo skinTo compare the resident memory T-cell infiltrate in perilesional vitiligo skin after 6 months of treatment with OMP and UVB, between three groups of patients suffering from non-segmental vitiligo, using flow cytometric analysis. * First group will include patients with a long-lasting disease (more than 2 years) and no new or growing lesions for at least 2 years: Old vitiligo with Old lesions * The second group will include patients with a long-lasting disease (more than 2 years) and with at least one new lesion developed in the last 6 months: Old vitiligo with new lesions * The third one will include patients developing, for the first-time, vitiligo lesions with all the lesions no older than 6 months: New vitiligo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Patients with non-segmental vitiligo. 3 groups of patients will be selected:
- Patients with a long-lasting disease (more than 2 years) and no new or growing lesion since at least 2 years
- Patients with a long-lasting disease (more than 2 years) and with at least one new lesion since less than 6 months
- Patients developing for the first-time vitiligo lesions with all the lesions no older than 6 months 2. ≥ 18 and <35 years to have a homogeneous distribution of age between the three groups, as 80% of vitiligo cases start before the age of 30.
- 3. Patient with at least one lesion of more than 2 cm² not located on the face, hands or feet.
Key exclusion criteria (3 listed)
- 1. Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration.
- 2. Segmental or mixed vitiligo 3. Vitiligo located only on face, hands and feet 4. Exposure to solar or artificial UV during the months before inclusion 5. Concomitant use of topical or systemic immunosuppressive medication or steroids 6. Patients suffering from photodermatosis or taking photosensitive drugs 7. Personal history of skin cancer. 8. Patients with diabetes, high blood pressure, osteoporosis or any other contra-indication to the use of systemic steroids.
- 9. Vulnerable people: pregnant or breast-feeding women, minors, adult under guardianship or deprived of freedom 10. Participants in other clinical therapeutic studies involving a drug that could interfere with the present evaluation
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 |
|---|---|---|
| The resident memory T-cell infiltrate in perilesional vitiligo skinThe 3 groups will receive a combination of narrowband UVB (Nb-UVB) 3 times a week and oral mini pulses of systemic steroids (5 mg of d medrol 16mg twice a week) for 24 weeks. Three visits will be done (inclusion, Week 12 and 24) A skin biopsy will be done on lesional and peri-lesional area at baseline. Another skin biopsy will be taken after 24 weeks but only in perilesional area. A blood sample for assessing the circulating memory T cells and for checking the tolerance will be performed at baseline, then at W12 and W24. | Other | the resident memory T-cell infiltrate in perilesional vitiligo skin |
Primary outcome
The percentage of resident memory T-cells (ratio memory T cells (CD4+CD69++ and CD8+CD69+)/Total CD4+ and CD8+ *100), assessed by cytometric analysis, in the perilesional skin of the target lesion.
Time frame: at 6 months
The target lesion will be chosen before any treatment. The minimal size will be 2cm². Considering that skin on the face usually responds very well whilst that of hands and feet respond poorly, to avoid potential bias due to the location of treatment, these locations won't be taken as target lesions. In any cases, no biopsy will be taken on the face or in the folds.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 37615581Marin Dit Bertoud Q, Bertold C, Ezzedine K, Pandya AG, Cherel M, Castillo Martinez A, Seguy MA, Abdallah M, Bae JM, Bohm M, Parsad D, Rosmarin D, Wolkerstorfer A, Bahadoran P, Blaise M, Dugourd PM, Philippo V, Delaval JM, Passeron T. Reliability and agreement testing of a new automated measurement method to determine facial vitiligo extent using standardized ultraviolet images and a dedicated algorithm. Br J Dermatol. 2023 Dec 20;190(1):62-69. doi: 10.1093/bjd/ljad304.
- Individual participant dataSharing planned: Undecided
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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.
Passeron Thierry, PhD principal investigator
CHU de Nice, Service de Dermatologie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The resident memory T-cell infiltrate in perilesional vitiligo skin in people with Vitiligo, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 7 inclusion and 3 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: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage of resident memory T-cells (ratio memory T cells (CD4+CD69++ and CD8+CD69+)/Total CD4+ and CD8+ *100), assessed by cytometric analysis, in the perilesional skin of the target lesion. (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843059, which also lists 1 linked publication.
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 2 Sep 2025.