ERASE VITILIGO Early Repigmentation Approach for Stopping the Evolution of VITILIGO Prospective Multicentric Interventional Study With Blinded Evaluation

NCT04843059 | Completed

• 1 other identifier: 21-PP-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• 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.

  at 6 months

Study Arms (1)

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

Other: The resident memory T-cell infiltrate in perilesional vitiligo skin

Interventions

The resident memory T-cell infiltrate in perilesional vitiligo skin OTHER

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 resident memory T-cell infiltrate in perilesional vitiligo skin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. Patient with at least one lesion of more than 2 cm² not located on the face, hands or feet.
• \. Affiliation to a social security system 7. Signed informed consent

You may not qualify if:

• \. Pregnant or breast-feeding women. Or women who plan to get pregnant during the study duration.
• \. 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice

Nice, alpes maritimes, 06001, France

Location

CHU Bordeaux

Bordeaux, 33440, France

Location

Related Publications (1)

• 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.

  PMID: 37615581 DERIVED

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Passeron Thierry, PhD

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: June 1, 2021
• Primary Completion: October 10, 2024
• Study Completion: August 18, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

FR (2)