Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma (BEST-CTCL)
Evaluation of the Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma
Background:
CTCL is a rare type of non-Hodgkin lymphoma that primarily affects the skin, causing red patches, plaques, and severe itching. Currently, topical corticosteroids are commonly used for early-stage disease, but long-term application can cause significant skin side effects such as atrophy. Benvitimod is a novel, non-steroidal aryl hydrocarbon receptor (AhR) agonist. Previous studies suggest it has the potential to inhibit tumor cell proliferation and reduce skin inflammation, providing a promising new targeted therapy for CTCL patients.
Study Design:
This is a prospective, single-center, double-blind, placebo-controlled study. To ensure a highly accurate comparison and eliminate individual differences, the study uses an intra-patient (left-right) control design. Approximately 35 patients will be enrolled.
Participants will have two comparable target lesions selected on opposite sides of their body (e.g., left and right trunk or limbs). They will be randomly assigned to apply benvitimod cream to the lesion on one side and a placebo cream to the matching lesion on the other side. The creams will be applied once daily for up to 24 weeks.
Researchers will evaluate the improvement in skin lesions (using the mSWAT score), reduction in itching (using the VAS score), and closely monitor any adverse events at weeks 2, 4, 8, 16, and 24 to assess both the effectiveness and safety of the treatment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients diagnosed with cutaneous T-cell lymphoma (CTCL) / mycosis fungoides (MF) by skin biopsy.
- Aged 18 years or older.
- Possess complete baseline clinical data.
- Good compliance with treatment and willing to attend follow-up visits.
- Conscious, with no cognitive impairment or communication barriers.
- Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
- Pregnant or lactating women, or those planning pregnancy within the next 6 months.
- Known allergy or hypersensitivity to benvitimod cream or its excipients.
- Severe ulceration or active infection at the target application sites.
- Unwilling or unable to sign the informed consent form.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Benvitimod treated side
The target lesion on one side of the body (left or right) randomly assigned to receive topical benvitimod cream.
|
Applied topically to the randomly assigned target lesion (left or right side) once daily for up to 24 weeks.
The application area will not exceed 2% of the body surface area.
Otros nombres:
|
|
Comparador de placebos: Placebo treated side
The matching target lesion on the contralateral side of the body assigned to receive placebo cream.
|
A vehicle cream matching the appearance of benvitimod cream.
Applied topically to the contralateral target lesion once daily for up to 24 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score
Periodo de tiempo: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
|
The mSWAT is used to assess the severity and extent of CTCL skin lesions.
The improvement rate is calculated as: (1 - post-treatment mSWAT score / baseline mSWAT score) * 100%.
A higher percentage indicates better clinical improvement of the skin lesions.
|
Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
|
|
Change in Pruritus Visual Analogue Scale (VAS) score
Periodo de tiempo: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
|
Patients will self-report the intensity of their itching using a Visual Analogue Scale (VAS) ranging from 0 to 10.
A score of 0 represents "no itch at all," and a score of 10 represents "the worst imaginable itch."
A decrease in the score from baseline indicates an improvement in pruritus.
|
Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Periodo de tiempo: Up to Week 24
|
The number of participants experiencing local adverse events (such as erythema, worsening pruritus, or contact dermatitis at the application site) and any systemic adverse events will be recorded and evaluated by clinicians to assess the safety of the topical treatment.
|
Up to Week 24
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- CTCLTA001
- 82425050 (Otro número de subvención/financiamiento: National Natural Science Foundation of China)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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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