Randomized Comparison of Low and Conventional Irradiance PDT for Skin Cancer
12 de diciembre de 2018 actualizado por: Sally Ibbotson
A Randomized Assessor-blinded Comparison of Low Irradiance and Conventional Irradiance Photodynamic Therapy (PDT) for Superficial Non-melanoma Skin Cancer
This study aims to examine whether the pain of topical photodynamic therapy (PDT) is significantly different when using low irradiance ambulatory light emitting diode (LED) devices compared with conventional higher irradiance hospital based LED light sources when used for superficial non-melanoma skin cancer.
The investigators are also investigating the phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A randomized assessor-blinded comparative study of low irradiance ambulatory LED devices with conventional hospital-based LED devices for superficial non-melanoma skin cancer.
Preliminary observations suggest that low irradiance LEDs cause less pain but are as effective, so the investigators are examining this in a clinical trial of patients with lesions </= 2cm diameter of non-melanoma skin cancer (Bowen's disease and superficial basal cell carcinoma).
Patients with these conditions referred to the PDT clinic will be invited to participate and if they are eligible and consent to treatment then they will be prospectively randomized to either ambulatory PDT or conventional PDT.
Pain and phototoxicity scores will be recorded and clinical efficacy will be assessed up to one year after the last treatment.
Computer-generated block randomization will be performed and at 90% power to detect as significant at the 5% level a mean difference in pain score of 2 in one group compared with 4 in the other, 36 patients will be needed, and as the participants will often be elderly and frail the investigators will aim for a safety margin of recruiting 50 participants to account for drop-outs.
Participants will receive two treatments of either arm at a one week interval and will be assessed clinically at three months and if residual disease remains then the two treatments a week apart are repeated.
Pain assessed using a visual analogue scale (VAS) score and phototoxicity on a semi-quantitative scale are recorded at 7 days when the participant returns for their second treatment.
Follow up for clinical assessment is at 6 months and one year after treatment.
Participants also give their opinion of treatment at one year follow up.
Assessors of adverse effects and efficacy will be blinded.
Data recording and analysis will be undertaken by the study statistician Dr Robert Dawe and analysis will be on an intention to treat basis using appropriate statistical tests comparing the pre-planned outcome measures, with pain as primary outcome and outcome, efficacy and patient satisfaction as secondary outcomes
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Bowen's disease or superficial basal cell carcinoma referred for PDT and lesion not greater than 2.4cm diameter
Exclusion Criteria:
- Unable to give consent, >2cm diameter, lesions on highly curved surfaces where ambulatory device would not adhere
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: low irradiance LED PDT
Ambulight LED portable PDT treatment
|
battery-operated low irradiance red light LED ("skin cancer plaster")
|
|
Comparador activo: conventional higher irradiance LED
Conventional LED hospital based standard PDT treatment
|
battery-operated low irradiance red light LED ("skin cancer plaster")
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain on VAS Score
Periodo de tiempo: one week after treatment
|
assess on visual analogue scale (VAS) score of 0 - 10cm, with 0 representing no pain experienced through to 10 representing the worst pain imaginable.
The participant marks across a 0-10cm unmarked line where their level of pain experience is and this is measured eg.
2cm if experiencing mild pain or 8.5cm which would represent severe pain
|
one week after treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phototoxicity
Periodo de tiempo: one week after treatment
|
erythema, oedema, blistering, crusting, ulceration on semi-quantitative scale. Erythema is graded as 0 = absent, 1 = mild, 2 = moderate or 3 = severe erythema as assessed by naked eye examination. Oedema is graded as 0 = absent or 1 = present. Likewise crusting or ulceration are each graded as 0 = absent and 1 = present by naked eye examination. Data will be presented and analysed separately ie. erythema data will be presented and then separately whether oedema, crusting or ulceration are present or absent. ie. reporting may appear as example: erythema score 3 of range of 0-3 options; oedema score 1 (binary option of 0 or 1); crusting score 0 (binary option of 0 or 1); ulceration score 0 (binary option of 0 or 1) |
one week after treatment
|
|
Clinical Clearance of Lesion
Periodo de tiempo: 12 months after treatment
|
clinical assessment by study dermatologist to determine by inspection and palpation whether the lesion is clear, partially clear or not clear - assessed at 3, 6 and 12 months after treatment, with 12 months as the final study outcome endpoint analysed
|
12 months after treatment
|
|
Patient Satisfaction
Periodo de tiempo: one year after treatment - last visit
|
brief patient questionnaire to evaluate their opinion of the treatment they received. This is assessed as A.efficacy of treatment - 1 = not effective NR; 2 = partIally effective PR; 3 = completely effective CR; B.Side effects of treatment eg. pain and inflammation - 1 = severe; 2 = moderate; 3 = mild; 4 = none/minimal. C.Practicalities of treatment eg. ease of use, travel, time, inconvenience - 1 = very disruptive and difficult; 2 = moderately disruptive and difficult; 3 = minimally disruptive and difficult. The scores of A, B and C will be added to give an overall score with range of overall minimum score option 3 and maximum 10. Patients will also separately be asked to give overall evaluation on a VAS scale of 0 = treatment very poor and would not have again through to 10 = treatment excellent and I would have again - with a continuous line option from 0 - 10 to mark across, providing a separate score with range options 0 to 10 |
one year after treatment - last visit
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sally H Ibbotson, MD, University of Dundee
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.
Publicaciones Generales
- Attili SK, Lesar A, McNeill A, Camacho-Lopez M, Moseley H, Ibbotson S, Samuel ID, Ferguson J. An open pilot study of ambulatory photodynamic therapy using a wearable low-irradiance organic light-emitting diode light source in the treatment of nonmelanoma skin cancer. Br J Dermatol. 2009 Jul;161(1):170-3. doi: 10.1111/j.1365-2133.2009.09096.x. Epub 2009 Mar 19.
- Moseley H, Allen JW, Ibbotson S, Lesar A, McNeill A, Camacho-Lopez MA, Samuel ID, Sibbett W, Ferguson J. Ambulatory photodynamic therapy: a new concept in delivering photodynamic therapy. Br J Dermatol. 2006 Apr;154(4):747-50. doi: 10.1111/j.1365-2133.2006.07145.x.
- Ibbotson SH. Irradiance is an important determinant of pain experienced during topical photodynamic therapy. J Am Acad Dermatol. 2011 Jul;65(1):201-2. doi: 10.1016/j.jaad.2010.11.060. No abstract available.
- Ibbotson SH, Ferguson J. Ambulatory photodynamic therapy using low irradiance inorganic light-emitting diodes for the treatment of non-melanoma skin cancer: an open study. Photodermatol Photoimmunol Photomed. 2012 Oct;28(5):235-9. doi: 10.1111/j.1600-0781.2012.00681.x.
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 octubre de 2011
Finalización primaria (Actual)
6 de febrero de 2017
Finalización del estudio (Actual)
6 de febrero de 2017
Fechas de registro del estudio
Enviado por primera vez
5 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
15 de agosto de 2016
Publicado por primera vez (Estimar)
19 de agosto de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
12 de diciembre de 2018
Última verificación
1 de diciembre de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2011DS04
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
peer reviewed publications and presentations at international and national meetings
Marco de tiempo para compartir IPD
presenting study data at British Association of Dermatologists annual meeting Edinburgh 5.7.18 and abstract will be published in Br J Dermatol and full publication will follow
Criterios de acceso compartido de IPD
via presentation and publication in peer-reviewed journal
Tipo de información de apoyo para compartir IPD
- Protocolo de estudio
- Plan de Análisis Estadístico (SAP)
- Formulario de consentimiento informado (ICF)
- Informe de estudio clínico (CSR)
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. .
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