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Aún no reclutaNCT07927699Registro de ClinicalTrials.gov

VItiligo RegisTry adUlts And chiLdren-France

Vitiligo

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
No especificado - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
100 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Vitiligo is a chronic skin disorder for which new therapeutic options, including topical and oral Janus kinase (JAK) inhibitors, are emerging. In this evolving therapeutic context, long-term follow-up of patients and documentation of their treatment history are important to better understand treatment outcomes and safety in routine clinical practice.

This study is a French multicenter pilot cohort conducted as a preliminary step toward the development of a national vitiligo registry. It aims to document the clinical course of patients with vitiligo, their treatments and treatment outcomes, and adverse events occurring during treatment. The study will also collect clinical, quality-of-life and patient-reported outcome data and explore potential factors associated with treatment failure or the occurrence of adverse events.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • Patient with a diagnosis of vitiligo, with no age restriction.
  • For adult participants: the patient has provided non-opposition to participation in the study.
  • For participants under 18 years of age: the holders of parental authority have provided non-opposition to the child's participation in the study.
  • Patient followed in the dermatology department of a participating center.

Exclusion Criteria:

  • Patient under legal protection (guardianship or curatorship).
  • Any difficulty in understanding or reading French that, in the investigator's opinion, could affect the validity of questionnaire completion.
  • Cognitive, mental, or psychiatric disorder that, in the investigator's opinion, prevents completion of the study protocol.

Población del estudio

Adults and children with a diagnosis of vitiligo followed in the dermatology department of one of the participating centers in France. Participants will be included regardless of age and will receive routine clinical care for vitiligo.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
Adults and pediatric Patients with vitiligo

Adults and children with a diagnosis of vitiligo followed in the dermatology department of a participating center. Participants receive routine clinical care for vitiligo. Clinical characteristics, current and previous treatments, treatment-related adverse events, disease severity, quality of life, and patient-reported outcomes are collected during follow-up

Other: Vitiligo treatments in routine clinical practice

Vitiligo treatments in routine clinical practice OTHER

Participants receive vitiligo treatments as part of routine clinical care. No treatment is assigned by the study protocol. Current and previous vitiligo treatments, including combination therapies, are documented during follow-up, together with clinical outcomes and treatment-related adverse events.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Clinical course of vitiligo under treatment assessed by T-VASI

Plazo: Baseline, 6 months, 1 year, and 2 years

Clinical course and disease severity in patients receiving currently used treatments for vitiligo, including combination therapies, will be assessed using the Total Vitiligo Area Severity Index (T-VASI). This assessment will be used to monitor changes in vitiligo severity during treatment

Clinical course of vitiligo under treatment assessed by sIGA

Plazo: Baseline, 6 months, 1 year, and 2 years

Clinical course and disease severity in patients receiving currently used treatments for vitiligo, including combination therapies, will be assessed using the Investigator Global Assessment (sIGA). This assessment will be used to monitor changes in vitiligo severity during treatment

Medidas secundarias

Descriptive data of BMI

Plazo: Baseline

Descriptive data of BMI will be done using mean and median.

Treatment-related adverse events

Plazo: Baseline, 6 months, 1 year, and 2 years

Adverse events occurring in patients receiving currently used treatments for vitiligo, including combination therapies.

Measure of the quality of life

Plazo: Baseline, 1 year, and 2 years

EQ-5D for adults participants.

Vitiligo burden

Plazo: Baseline, 6 months, 1 year, and 2 years

Vitiligo burden will be assessed using the Vitiligo Impact Patient scale (VIPs).

Change in vitiligo disease activity assessed by the Vitiligo Signs of Activity Score (VSAS)

Plazo: Baseline, 6 months, 1 year, and 2 years

Vitiligo disease activity will be assessed using the Vitiligo Signs of Activity Score (VSAS). Changes in VSAS scores will be monitored over time to evaluate disease activity during follow-up.

Patient Self-reported Vitiligo extent (SA-VES)

Plazo: Baseline, 6 months, 1 year, and 2 years

Patients self-reported of disease extent will be assessed by the Self-Assessment Vitiligo Extent Score (SA-VES).This assessment will be used to monitor changes in the extent of vitiligo over time

Feasibility of the multicenter vitiligo registry

Plazo: Through study completion, up to 5 years

Number of participants enrolled, missing data, and participants lost to follow-up.

Measure of the quality of life

Plazo: Baseline, 1 year, and 2 years

Child DLQI for pediatric participants.

Age of participants at enrollment

Plazo: Baseline

Age of participants at enrollment will be recorded in years and summarized using descriptive statistics.

Distribution of participants by sex

Plazo: Baseline

The number and percentage of participants in each recorded sex category will be reported.

Number of participants with comorbidities

Plazo: Baseline, 1 year, and 2 years

The number and percentage of participants with at least one recorded comorbidity will be reported.

Number of participants with previous treatments for vitiligo

Plazo: Baseline

The number and percentage of participants who received treatment for vitiligo prior to enrollment will be reported.

Number of participants with a history of cancer

Plazo: Baseline, 1 year, and 2 years

The number and percentage of participants with a recorded diagnosis of cancer, including skin cancer, will be reported.

F-VASI - Facial extent of vitiligo

Plazo: Baseline, 6 months, 1 year, and 2 years

Facial vitiligo severity will be assessed using the Facial Vitiligo Area Severity Index (F-VASI). This assessment will be used to monitor changes in facial vitiligo severity over time

VNS - Patient reported Vitiligo noticeability scale (VNS)

Plazo: Baseline, 6 months, 1 year, and 2 years

Vitiligo noticeability will be assessed using the Vitiligo Noticeability Scale (VNS). This assessment will be used to monitor changes in the perceived noticeability of vitiligo over time

PHQ-4 - Patient Health Questionnaire to measure Psychological distress

Plazo: Baseline, 6 months, 1 year, and 2 years

Psychological distress will be assessed using the Patient Health Questionnaire-4 (PHQ-4). Changes in PHQ-4 scores will be monitored over time to evaluate psychological distress during follow-up

GAD-7 - Anxiety assessment

Plazo: Baseline, 6 months, 1 year, and 2 years

Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7). Changes in GAD-7 scores will be monitored over time to evaluate anxiety symptoms during follow-up

PUSH-D - Stigma linked to vitiligo

Plazo: Baseline, 6 months, 1 year, and 2 years

Perceived and enacted stigma of vitiligo changes will be assessed using the PUSH-D questionnaire. Changes in PUSH-D scores will be monitored over time during follow-up

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Assistance Publique Hôpitaux de ParisCréteil, FranceEstado desconocido

Equipo y fechas

Patrocinador principal
Assistance Publique - Hôpitaux de Paris
Inicio del estudio
2026-11 Estimado
Finalización primaria
2031-11 Estimado
Finalización del estudio
2031-11 Estimado
Primera publicación
10 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Khaled EZZEDINE, MD, PhDCONTACTkhaled.ezzedine@aphp.fr01 49 81 25 36
Título oficial del estudio

VItiligo RegisTry adUlts And chiLdren-France

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026