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Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.

3 de febrero de 2009 actualizado por: Renovo

A Double Blind, Placebo Controlled, Randomised Trial to Investigate the Efficacy of Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.

This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following surgical scar revision.

In addition, this study will compare the scar revision techniques of complete excision (excision of the entire scar during one surgical procedure) and staged excision (excision of the outmost segments and central core separately).

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

60

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Manchester, Reino Unido, M13 9XX
        • Renovo Clinical Trials Unit

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Subjects aged 18-85 years who have provided written informed consent.
  • A body mass index between 15 and 35 kg/m2 .
  • Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
  • Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.
  • Subjects with linear scars that, in the opinion of the Investigator, are suitable for revision by excision and direct closure. The area of scar to be revised must be at least 5cm in length and have at least two comparable areas.
  • Subjects, who, in the opinion of the Investigator have stabilised, mature scars.

Exclusion Criteria:

  • Subjects who on direct questioning and physical examination have history or evidence of keloid scarring.
  • Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar.
  • Subjects with additional scars less than 3cm away from the area to be revised.
  • Subjects with a history of a bleeding disorder.
  • Subjects with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
  • Subjects who have had surgery in the area to be excised within one year of Day 0.
  • Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
  • Subjects who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
  • Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
  • Subjects who are taking, or have taken, any investigational drugs including Juvista within 3 months prior to the screening visit.
  • Subjects who are taking regular, continuous, oral corticosteroid therapy.
  • Subjects who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits.
  • Subjects undergoing investigations or changes in management for an existing medical condition.
  • Subjects who are or who become pregnant up to and including Day 0 or who are lactating.
  • In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: 1
Complete Scar Excision

Complete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration.

Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration.

Comparador de placebos: 2
Staged Excision of scar

Complete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration.

Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Investigator scar assessment
Periodo de tiempo: up to 7 month visit
up to 7 month visit
Patient scar assessment
Periodo de tiempo: up to 7 month visit
up to 7 month visit
Independent scar assessment
Periodo de tiempo: up to month 7
up to month 7

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Local tolerability
Periodo de tiempo: up to month 7
up to month 7
Adverse events
Periodo de tiempo: up to month 7
up to month 7

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: D A McGrouther, FRCS MD, University of Manchester

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2006

Finalización primaria (Anticipado)

1 de julio de 2008

Finalización del estudio (Anticipado)

1 de septiembre de 2012

Fechas de registro del estudio

Enviado por primera vez

6 de febrero de 2007

Primero enviado que cumplió con los criterios de control de calidad

6 de febrero de 2007

Publicado por primera vez (Estimar)

7 de febrero de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

4 de febrero de 2009

Última actualización enviada que cumplió con los criterios de control de calidad

3 de febrero de 2009

Última verificación

1 de febrero de 2009

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • RN1001-319-1009

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. .

Ensayos clínicos sobre Avotermin

3
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