Interest of the Dermabrasion by Laser Erbium in the Treatment of the Vitiligo
The treatment of vitiligo remains disappointing especially in some localization such as bony prominences and extremities. The association of UVB and topical steroids has been proven to be synergistic but the results are still insufficient in those difficult to treat areas. Promising results have been shown with the combination of laser assisted dermabrasion, topical 5FU and UVB. The investigators hypothesize that the dermabrasion of vitiligo skin followed by topical steroids should potentialized the effect of UVB and be superior to topical steroids and UVB without dermabrasion.
The main objective of this study is to evaluate the usefulness of laser assisted dermabrasion combined to topical steroids and UVB phototherapy in difficult to treat areas.
Patients with symmetrical non segmental vitiligo will be included in this prospective randomized monocentrer study. The investigators calculated the number of patients needed at 25. The side that will receive the dermabrasion will be centrally randomized and the opposite side will serve as control. Then on both side class 3 topical steroids will be applied daily 3 weeks on 4 for 12 weeks. UVB phototherapy will be performed twice weekly also for 12 weeks.
The evaluation will be performed by two independent physician blinded to the treatment of standardized photos before and 1 month after the end of the treatment. The criteria of success will be at least 75% of repigmentation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Alpes-Maritimes
-
Nice, Alpes-Maritimes, Francia, 06001
- CHU de Nice - 4 avenue Reine Victoria - Hôpital de Cimiez
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age between 18 at 85
- Not segmental Vitiligo of clinical diagnosis located on bony projections or of ends
- Two symmetrical plates of vitiligo of more than 4 cm ²
Exclusion Criteria:
- Pregnant women or breastfeeding.
- Vitiligo lesions on face and neck
- Personal history of skin cancer
- Photosensitize drugs
- Personal history of photodermatosis
- Personal history of keloids
- Concomitant treatment that could have an action on vitiligo (such as tacrolimus or pimecrolimus).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Group Laser = Arm As A
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
|
Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
|
|
Comparador de placebos: Bras B : the control group
patient to accept habitual treatment of corticoid
|
patient to accept habitual treatment of corticoid Opposite side lesions that will receive only the treatment by topical steroids
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Lesions that will receive the treatment by dermabrasion associate to habitual treatment of topical steroids and UVB phototherapy
Periodo de tiempo: 4 months
|
Opposite side lesions that will received only the treatment by topical steroids and UVB phototherapy
|
4 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: PASSERON Ph Thierry, Md, CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 09-PP-08
- 2010-A00021-38 (Otro número de subvención/financiamiento: AFSSAPS)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .