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

Phase 2Not Yet RecruitingNCT07658924

Peking University First Hospital35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cutaneous T-Cell Lymphoma

Interventions

Benvitimod CreamDRUG

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.

Placebo creamDRUG

A vehicle cream matching the appearance of benvitimod cream. Applied topically to the contralateral target lesion once daily for up to 24 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score

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.

Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24

Change in Pruritus Visual Analogue Scale (VAS) score

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.

Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24

Secondary Outcomes

Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)

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.

Time frame: Up to Week 24