Evaluating Photodynamic Therapy Used to Treat Cutaneous Squamous Cell Carcinoma in Situ (isSCC) on the Face, Upper Extremities & Trunk.
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) With Blue Light Model 4170E in the Treatment of Cutaneous Squamous Cell Carcinoma in Situ (isSCC) Located on the Face, Upper Extremities and Trunk.
The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, upper extremities and trunk, using a light sensitive cream used in combination with a light source.
The main questions this trial aims to answer are:
- to confirm using laboratory testing, how much of the affected skin cancer section the treatment was able to remove, and;
- seeing how many participants had no remaining affected skin cancer sections after treatment.
Participants who qualify will be asked to complete 12 visits in total and will receive a total of two treatments, after voluntarily consent has been given.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
In the study, participants will be asked to complete the following:
- Provide basic personal information (including date of birth, gender, race and ethnicity)
- Provide their medical/ surgical history and perform a medical exam (including but not limited to physical exam, skin type, vital signs, height, weight and urine pregnancy test collection)
- Follow study rules such as avoiding certain medications and treatments
- Allow photographs of the area of skin cancer being treated on the face or upper extremities/ trunk.
- Provide information on any medications, treatments or reactions that started after the study began
- Allow two treatments on the skin cancer area of the face upper extremities/ trunk using a light sensitive cream used in combination with a light source
- Allow clinical documentation of the treatment, such as how well the treatment was tolerated, any skin reaction or side effects
- Allow surgery to remove the skin cancer area from the face or upper extremities/ trunk for Laboratory testing
To qualify for this trial, participants must:
- be an adult (18 years of age or older)
- give voluntary written consent
- have a recently diagnosed (less than six months from first visit) skin cancer area on the face or upper extremities/ trunk that meets surgery size requirements
- be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
- (if female) not be pregnant before and during the study and agree to use acceptable forms of birth control
- confirm they are not sensitive to any of the study treatment ingredients
All surgery samples collected from the participants towards the end of the study will be sent to a laboratory for testing.
All photographs of the treatment area collected during the study will be used as study data.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Clinical Coordinator
- Número de teléfono: 305-933-6716
- Correo electrónico: info@centerforclinicalandcosmeticresearch.com
Ubicaciones de estudio
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Florida
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Aventura, Florida, Estados Unidos, 33180
- Reclutamiento
- Center for Clinical and Cosmetic Research
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Contacto:
- Clinical Coordinator
- Número de teléfono: 305-933-6716
- Correo electrónico: info@centerforclinicalandcosmeticresearch.com
-
Investigador principal:
- Mark S. Nestor, MD, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Must be an adult (18 years of age or older).
- Voluntary written consent required.
- Must have a recently diagnosed (no more than six months from first study visit) facial or trunk/ upper extremities isSCC (Squamous Cell Carcinoma in situ) lesion that meets surgery excision size requirements.
- Cannot have other dermatological disease in the isSCC target area.
- Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas.
- If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control.
Exclusion Criteria:
- Sensitive to any of the study treatment ingredients.
- Pregnant or lactating.
- Medical laboratory evidence of other non-isSCC tumor in the target lesion biopsy specimen.
- History of recurrence in the target isSCC lesion.
- Medical laboratory evidence of certain growth patterns in the target lesion biopsy specimen.
- Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety.
- History of abnormal heart muscles.
- Currently participating in a research study or have been treated with an investigational product within 30 days from first study treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Facial isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)
8 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.
Otros nombres:
|
|
Experimental: Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 20 J/cm2)
8 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 16 minutes and 40 seconds to deliver the total desired light dose to the isSCC lesion.
Otros nombres:
|
|
Experimental: Facial isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)
7 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.
Otros nombres:
|
|
Experimental: Trunk and/or upper extremities isSCC Photodynamic Therapy (Blue light dose 10 J/cm2)
7 participants will be enrolled to this arm. |
Participants will have their isSCC lesions prepped then treated with Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick® Applicators) (ALA), followed by Blue Light therapy administered for 8 minutes and 20 seconds to deliver the total desired light dose to the isSCC lesion.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of participants with Histological Clearance of treated isSCC lesion
Periodo de tiempo: Up to 63 days after treatment 2.
|
Histological clearance is defined as the absence of detectable evidence of isSCC tumor cell nests by the central pathology reports |
Up to 63 days after treatment 2.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of participants with clinical clearance of treated isSCC lesion
Periodo de tiempo: Up to 63 days after treatment 2.
|
Complete Clinical Clearance will be measured by the Investigator and is defined as when there is no clinically visible lesion remaining at the site. |
Up to 63 days after treatment 2.
|
|
Local Skin Response Scale
Periodo de tiempo: Up to 63 days after treatment 2
|
Observations and changes noted in the aesthetic appearance of the treated isSCC lesion site. |
Up to 63 days after treatment 2
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mark S Nestor, MD, PhD, Center for Clinical and Cosmetic Research
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Enfermedades de la piel
- Carcinoma
- Neoplasias De Células Escamosas
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Hallazgos morfológicos y microscópicos
- Carcinoma De Células Escamosas
- Neoplasias De La Piel
- Lesiones intraepiteliales escamosas
- Aminoácidos, péptidos y proteínas
- Químicos orgánicos
- Preparaciones farmacéuticas
- Fenómeno físico
- Ácidos carboxílicos
- Aminoácidos
- Fenómenos electromagnéticos
- Fenómeno magnético
- Radiación electromagnética
- Radiación
- Luz
- Fenómeno óptico
- Radiación, nonionizante
- Ácidos ceto
- Ácidos levulínicos
- Ácido aminolevulínico
- Soluciones
- Luz Azul
Otros números de identificación del estudio
- CCCR 02-2024
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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