Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma

Patrocinadores

Patrocinador principal: Shahid Beheshti University of Medical Sciences

Fuente Shahid Beheshti University of Medical Sciences
Resumen breve

The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors that affect response rate.

Descripción detallada

Background and Aim: Basal cell carcinoma (BCC) is the most common skin cancer .Photodynamic therapy _as a novel , non-invasive therapeutic approach _may be considered a valuable strategy. This study was designed with the aim of the evaluation of efficacy of PDT in treatment of BCC and factors that may affect response rate.

Materials and Methods: This was a clinical trial which was done on 28 BCCs. Patients were treated with ALA-PDT monthly for 1-6 sessions and evaluated for clinical response,cosmetic results and probable side effects.

Estado general Completed
Fecha de inicio January 2008
Fecha de Terminación March 2009
Fecha de finalización primaria July 2008
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Clinical Response to Photodynamic Therapy immediately after termination of treatment course (with an average of 5 month after initiation of PDT)
Resultado secundario
Medida Periodo de tiempo
Histologic Resolution of Lesion immediately after the terminaton of treatment course (with an average of 5 months after initiation of PDT)
Inscripción 28
Condición
Intervención

Tipo de intervención: Radiation

Nombre de intervención: photodynamic therapy

Descripción: treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly

Etiqueta de grupo de brazo: BCC, ALA-PDT

Otro nombre: PDT 1200L Waldman Medizintechnik; Schwenningen, Germany

Elegibilidad

Criterios:

Inclusion Criteria:

- Histologically proven BCCs

Exclusion Criteria:

- rodent ulcer

- morphea type

- ANA +

- history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during last month

- pregnancy

- breast feeding

- age< 18

- history of another therapeutic intervention for bcc during last 6 months

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Zohreh Tehranchi-nia, assist.prof. Principal Investigator Skin Research Center
Fecha de verificación

November 2009

Fiesta responsable

Nombre Titulo: Zohreh Tehranchi-nia

Organización: assistant professor of dermatology Shaheed Beheshti Medical University

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: BCC, ALA-PDT

Tipo: Experimental

Descripción: Patients with histologically proven basal cell carcinoma who were candidates for treatment with ALA-PDT

Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Single Group Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov