A Clinical Research Study for Adults Living with Stable Vitiligo

Objetivo

The purpose of this study is to evaluate the safety and effectiveness of a procedure using the RECELL® System for repigmentation of stable vitiligo. Stable vitiligo means that for at least 12 months:

• Areas affected by loss of pigment have not increased in size.

• No new areas with pigment loss have developed.

The RECELL System is used to prepare a suspension (a liquid solution) of skin cells using a small sample of your own pigmented skin. The suspension made using your own skin includes cells responsible for pigmentation and will be applied on a depigmented area of your skin.

Vitiligo is a skin condition in which there is a loss of color (referred to as “depigmentation”) from areas of skin. This results in uneven white patches that have no pigment, but the skin feels normal.

Depigmentation may be treated with lotions and light therapy, but sometimes these do not result in satisfactory outcomes. In those cases, a new procedure may be done that takes the pigment producing cells you have and places them onto your depigmented area.

This RSVP study is evaluating a new procedure using the RECELL® System to treat stable vitiligo in patients 18 years of age or older. The use of the RECELL System for this purpose is not currently approved and is therefore investigational.

Palabras clave: Vitiligo, Vitiligo treatment, mild vitiligo, severe vitiligo, vitiligo cure, stable vitiligo, loss of pigment in skin, loss of pigmentation

Sitios de estudio

830 Flower St #A100, Los Angeles, CA 90017

 
  • Men & Women
Age icon
18 +
 
 

You may qualify to participate in this study if:

  • You have tried topical and light therapy and did not see results.
  • Your vitiligo has been stable for at least 12 months (no increase in size of areas and no new areas).
  • You are at least 18 years of age.
If you would like more information or feel you may qualify, please email our Study Coordinator, Giselle, at Giselle.Garcia@med.usc.edu.
O
 

¿Qué hay involucrado?

Duración del ensayo

  • Participation in the study will last 52 weeks after you receive study treatment.

  • Participating is voluntary. If you choose to join this study, you can change your mind and leave the study at any time. This will not affect other medical care you may receive.

Número de visitas

  • After treatment, you will visit your study doctor six times in the 52 weeks that follow your study treatment.

Prescripción

  • If you participate in this study, you will:

  • • Identify two depigmented areas with your doctor. One of the study areas will receive with the RECELL System.**

  • • Treat both study areas at home with a provided phototherapy system.

  • ** After you have completed the study, you may be given the option for RECELL treatment of your study area(s) without pigment, at no cost to you.

Procedimiento

  • Pigmented Cell Solution

  • Phototherapy

Compensation

  • Compensation is available for successful completion of study visits.

Cobertura de gastos médicos

  • Study-related care at no cost to you.

Elegibilidad

Criterios de inclusión

  • You have tried topical and light therapy and did not see results.
  • Your vitiligo has been stable for at least 12 months (no increase in size of areas and no new areas).
  • You are at least 18 years of age.

Equipo del Programa

Photohandler
Investigador Principal
Nada Elbuluk, MD

For questions about this study, contact:

Research study materials

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