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Estudio Clínico sobre los Dispositivos Médicos PROXERA PSOMED 20 y PROXERA PSOMED 40 para el Tratamiento de la Psoriasis en Placas y la Psoriasis Palmoplantar no Pustulosa (PASI)

26 de julio de 2026 actualizado por: ICIM International S.r.l.

Evaluación de la Eficacia y Seguridad del Dispositivo Médico PROXERA PSOMED 20 en la Reducción de Placas Psoriásicas y del Dispositivo Médico PROXERA PSOMED 40 en la Reducción de la Lesión de Psoriasis Palmoplantar no Pustulosa en Pacientes con Psoriasis en Placas: un Estudio Patrocinado, Intervencionista, Monocéntrico, Aleatorizado, Simple Ciego, Controlado Intra-paciente (PASI)

Este estudio intervencionista de un solo centro se diseñó para evaluar la eficacia y seguridad de dos dispositivos médicos tópicos con marcado CE: PROXERA PSOMED 20 se estudia en participantes con psoriasis en placas no palmoplantar, mientras que PROXERA PSOMED 40 se estudia en participantes con psoriasis palmoplantar no pustulosa.

El estudio tiene como objetivo determinar si el tratamiento de un área objetivo con el dispositivo médico asignado produce una mayor mejoría clínica en comparación con el área contralateral de control no tratada en el mismo participante. Para PROXERA PSOMED 20, la evaluación principal se realiza después de 4 semanas de tratamiento. Para PROXERA PSOMED 40, la evaluación principal se realiza después de 8 semanas de tratamiento.

Los objetivos secundarios incluyen la evaluación de la seguridad, la tolerabilidad local, la progresión general de la psoriasis, su impacto en la calidad de vida y parámetros adicionales de la actividad local de la enfermedad en las áreas objetivo. Los participantes aplicarán el dispositivo de estudio asignado una vez al día en el área objetivo seleccionada, se someterán a evaluaciones clínicas en las visitas programadas y proporcionarán información sobre seguridad y tolerabilidad durante todo el estudio.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

35

Fase

  • No aplica

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.

Estudio Contacto

  • Nombre: Paolo Amerio, Professore Ordinario
  • Número de teléfono: + 39 0871358032
  • Correo electrónico: paolo.amerio@unich.it

Ubicaciones de estudio

  • Italia
    • Italia
      • Chieti, Italia, Italia, 66100
        • Reclutamiento
        • Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio
        • Contacto:

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

PROXERA PSOMED 20 - crema normalizadora, 20% de urea

  • Diagnóstico de psoriasis en placas (no palmoplantar) durante al menos 1 año PROXERA PSOMED 40 - gel exfoliante intensivo, 40% de urea
  • Diagnóstico de psoriasis palmoplantar no pustulosa durante al menos 1 año

Criterios de inclusión comunes:

  • Edad 18-65 años
  • Gravedad de la psoriasis "leve" según:
  • Índice de Gravedad y Área de Psoriasis (PASI) <10
  • Índice de Calidad de Vida Dermatológico (DLQI) <10
  • Área de Superficie Corporal (BSA) <10

Criterios de exclusión:

  • Intolerancia al producto
  • Terapia concomitante con fármacos inmunomoduladores sistémicos (por ejemplo, metotrexato, ciclosporina, apremilast)
  • Terapia concomitante con fármacos biológicos como anti-TNFα, anti-IL17 o anti-IL23.
  • Terapia tópica concomitante con corticosteroides tópicos (TCT), inhibidores tópicos de la calcineurina (ITC), análogos de la vitamina D y combinaciones.
  • Mujeres embarazadas o en periodo de lactancia

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Tratamiento Intra-paciente Con PROXERA PSOMED 20
Brazo de estudio controlado, aleatorizado, de un solo grupo, ciego simple e intrapaciente. Los participantes se asignan al tratamiento según el diagnóstico: los participantes con psoriasis en placas no palmoplantar reciben PROXERA PSOMED 20 una vez al día durante 4 semanas en una placa objetivo, mientras que los participantes con psoriasis palmoplantar no pustulosa reciben PROXERA PSOMED 40 una vez al día durante 8 semanas en un área objetivo de la palma o la planta del pie. En ambas cohortes, un área objetivo contralateral comparable permanece sin tratar como control. Para PROXERA PSOMED 40, el tratamiento se interrumpe durante 3 días cada 14 días.
Dispositivo: Crema PROXERA PSOMED 20; Gel PROXERA PSOMED 40

Proxera Psomed 20: Dispositivo médico tópico en formulación de crema que contiene un 20% de urea, suministrado en un tubo de 200 mL. El participante se lo aplica una vez al día a la misma hora sobre la placa objetivo seleccionada durante 4 semanas, según la regla de la unidad de la punta del dedo. El área objetivo contralateral comparable permanece sin tratar como control.

Proxera Psomed 40: Dispositivo médico tópico en formulación de gel que contiene un 40% de urea, suministrado en un tubo de 100 mL. El participante se lo aplica una vez al día a la misma hora sobre el área objetivo seleccionada de la palma o la planta del pie durante 8 semanas, según la regla de la unidad de la punta del dedo. El tratamiento se interrumpe durante 3 días cada 14 días. El área objetivo contralateral comparable permanece sin tratar como control.

Otros nombres:
  • PROXERA PSOMED 40 - gel exfoliante intensivo, 40% de urea
  • PROXERA PSOMED 20 - crema normalizadora, 20% urea
Experimental: Tratamiento Intra-paciente Con PROXERA PSOMED 40
Los participantes con psoriasis palmoplantar no pustulosa se aplican PROXERA PSOMED 40 una vez al día, a la misma hora, en un área objetivo de la palma o la planta del pie durante 8 semanas.
La dosis se aplica según la regla de la unidad de la yema del dedo.
Un área objetivo contralateral comparable permanece sin tratar como control.
El tratamiento se interrumpe durante 3 días cada 14 días.
Dispositivo: Crema PROXERA PSOMED 20; Gel PROXERA PSOMED 40

Proxera Psomed 20: Dispositivo médico tópico en formulación de crema que contiene un 20% de urea, suministrado en un tubo de 200 mL. El participante se lo aplica una vez al día a la misma hora sobre la placa objetivo seleccionada durante 4 semanas, según la regla de la unidad de la punta del dedo. El área objetivo contralateral comparable permanece sin tratar como control.

Proxera Psomed 40: Dispositivo médico tópico en formulación de gel que contiene un 40% de urea, suministrado en un tubo de 100 mL. El participante se lo aplica una vez al día a la misma hora sobre el área objetivo seleccionada de la palma o la planta del pie durante 8 semanas, según la regla de la unidad de la punta del dedo. El tratamiento se interrumpe durante 3 días cada 14 días. El área objetivo contralateral comparable permanece sin tratar como control.

Otros nombres:
  • PROXERA PSOMED 40 - gel exfoliante intensivo, 40% de urea
  • PROXERA PSOMED 20 - crema normalizadora, 20% urea

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 4
Periodo de tiempo: Baseline to Week 4 (end of treatment)
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling. Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity. In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 4 in the treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 8
Periodo de tiempo: Baseline to Week 8 (end of treatment)
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area. Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6. For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease. In participants treated with PROXERA PSOMED 40, the primary analysis compares the change from baseline to Week 8 in the treated target area with the change in the contralateral untreated control area.
Baseline to Week 8 (end of treatment)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Target Lesion Score at Week 8
Periodo de tiempo: Baseline to Week 8 (4 weeks after the end of treatment)
The Target Lesion Score assesses the severity of a representative psoriatic plaque based on erythema, induration (thickness), and scaling. Each component is scored from 0 to 4, and the total score ranges from 0 to 12, with higher scores indicating greater lesion severity. In participants treated with PROXERA PSOMED 20, the outcome compares the change from baseline to Week 8 in the treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 8 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Local Modified Palmoplantar Psoriasis Area and Severity Index at Week 12
Periodo de tiempo: Baseline to Week 12 (4 weeks after the end of treatment)
The local modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) assesses erythema, induration, scaling, and extent of involvement in each target palm or sole area. Erythema, induration, and scaling are each scored from 0 to 4, while extent of involvement is scored from 0 to 6. For each target site, the local score is calculated as (erythema + induration + scaling) × extent and ranges from 0 to 72, with higher scores indicating more severe disease. In participants treated with PROXERA PSOMED 40, the outcome compares the change from baseline to Week 12 in the treated target area with the change in the contralateral untreated control area.
Baseline to Week 12 (4 weeks after the end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
Periodo de tiempo: Baseline to Week 4 (end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 4 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20. The assessment is used to determine whether changes observed in the target plaque occur independently of, or in parallel with, changes in overall psoriasis severity.
Baseline to Week 4 (end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
Periodo de tiempo: Baseline to Week 8 (end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 8 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40. The assessment is used to determine whether changes observed in the target palm or sole area occur independently of, or in parallel with, changes in overall psoriasis severity.
Baseline to Week 8 (end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
Periodo de tiempo: Baseline to Week 8 (4 weeks after the end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 8 in participants with non-palmoplantar plaque psoriasis treated with PROXERA PSOMED 20. The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Change From Baseline in Psoriasis Area and Severity Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
Periodo de tiempo: Baseline to Week 12 (4 weeks after the end of treatment)
The Psoriasis Area and Severity Index (PASI) assesses overall psoriasis severity by combining the extent of body surface involvement with the severity of erythema, induration, and scaling across different body regions. The total PASI score ranges from 0 to 72, with higher scores indicating greater overall psoriasis severity. This outcome measures the change in PASI score from baseline to Week 12 in participants with non-pustular palmoplantar psoriasis treated with PROXERA PSOMED 40. The assessment evaluates overall psoriasis severity 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 4 in the PROXERA PSOMED 20 Cohort
Periodo de tiempo: Baseline to Week 4 (end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 4 in participants treated with PROXERA PSOMED 20.
Baseline to Week 4 (end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 40 Cohort
Periodo de tiempo: Baseline to Week 8 (end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 40.
Baseline to Week 8 (end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 8 in the PROXERA PSOMED 20 Cohort
Periodo de tiempo: Baseline to Week 8 (4 weeks after the end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 8 in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Change From Baseline in Dermatology Life Quality Index Score at Week 12 in the PROXERA PSOMED 40 Cohort
Periodo de tiempo: Baseline to Week 12 (4 weeks after the end of treatment)
The Dermatology Life Quality Index (DLQI) is a 10-item questionnaire that assesses the impact of skin disease on the participant's daily life, including symptoms, daily activities, leisure, work or school, personal relationships, and treatment. Each item is scored from 0 to 3. The total score ranges from 0 to 30, with higher scores indicating a greater negative impact on quality of life. This outcome measures the change in DLQI score from baseline to Week 12 in participants treated with PROXERA PSOMED 40, 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 4
Periodo de tiempo: Baseline to Week 4 (end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 4 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 8
Periodo de tiempo: Baseline to Week 8 (end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area.
Baseline to Week 8 (end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Transepidermal Water Loss at Week 8
Periodo de tiempo: Baseline to Week 8 (4 weeks after the end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 8 in the PROXERA PSOMED 20-treated target plaque with the change in the contralateral untreated control plaque, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Areas in Change From Baseline in Transepidermal Water Loss at Week 12
Periodo de tiempo: Baseline to Week 12 (4 weeks after the end of treatment)
Transepidermal water loss (TEWL) is measured non-invasively using the DermaLab Combo system to assess epidermal barrier function. Higher TEWL values indicate greater water loss and greater impairment of the skin barrier. This outcome compares the change from baseline to Week 12 in the PROXERA PSOMED 40-treated target palm or sole area with the change in the contralateral untreated control area, 4 weeks after the end of treatment.
Baseline to Week 12 (4 weeks after the end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 4
Periodo de tiempo: Baseline to Week 4 (end of treatment)
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque. This outcome compares the change in vascular density from baseline to Week 4 between the two target plaques in participants treated with PROXERA PSOMED 20.
Baseline to Week 4 (end of treatment)
Difference Between Treated and Untreated Target Plaques in Change From Baseline in Vascular Density at Week 8
Periodo de tiempo: Baseline to Week 8 (4 weeks after the end of treatment)
Vascular density is assessed non-invasively by dermato-capillaroscopy and is recorded separately for the treated target plaque and the contralateral untreated control plaque. This outcome compares the change in vascular density from baseline to Week 8 between the two target plaques in participants treated with PROXERA PSOMED 20, 4 weeks after the end of treatment.
Baseline to Week 8 (4 weeks after the end of treatment)
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 20 Cohort
Periodo de tiempo: From first application through Week 8
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator. Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis. The outcome is the number and proportion of participants experiencing at least one adverse event.
From first application through Week 8
Number of Participants With One or More Adverse Events in the PROXERA PSOMED 40 Cohort
Periodo de tiempo: From first application through Week 12
All solicited and unsolicited adverse events, adverse device effects, and serious adverse events occurring during treatment or follow-up will be recorded and assessed by the investigator. Particular attention will be given to local reactions such as burning, erythema, itching, skin rash, irritation, and allergic contact dermatitis. The outcome is the number and proportion of participants experiencing at least one adverse event.
From first application through Week 12

Colaboradores e Investigadores

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

Patrocinador

ICIM International S.r.l.

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 (Actual)

30 de abril de 2026

Finalización primaria (Estimado)

25 de noviembre de 2026

Finalización del estudio (Estimado)

23 de diciembre de 2026

Fechas de registro del estudio

Enviado por primera vez

16 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de abril de 2026

Publicado por primera vez (Actual)

22 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de julio de 2026

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

26 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • Id 286

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Los datos individuales de los participantes no estarán disponibles públicamente. Los datos del estudio son confidenciales y propiedad del Patrocinador. Los datos de los participantes se manejan cumpliendo las leyes de protección de datos aplicables y se codifican para proteger la confidencialidad. Cualquier publicación de los resultados del estudio está sujeta a la revisión y aprobación del Patrocinador y del Investigador Principal, de acuerdo con la política de publicación del estudio.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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