Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma

Официальное название

Evaluation of the Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score [Срок оценки: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24]
• Change in Pruritus Visual Analogue Scale (VAS) score [Срок оценки: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24]

Вторичные конечные точки (1)

• Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) [Срок оценки: Up to Week 24]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07658924 · CTCLTA001 · 82425050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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