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

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

Interventions

OTHER

The resident memory T-cell infiltrate in perilesional vitiligo skin

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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice

  lead OTHER

Principal Investigators

• Passeron Thierry, PhD · CHU de Nice, Service de Dermatologie

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2024-10-10

Completion

2025-08-18

Countries

• France

Study Locations