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Not yet recruiting NCT07658924

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

Phase II Interventional Cutaneous T-Cell Lymphoma Mycosis Fungoides (MF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Benvitimod Cream, Placebo cream.
Who it may be relevant to
Registry conditions: Cutaneous T-Cell Lymphoma, Mycosis Fungoides (MF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug 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.
  • Drug 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.

Primary outcome measures

  • Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score [Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24]
  • Change in Pruritus Visual Analogue Scale (VAS) score [Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24]
Secondary outcome measures (1)
  • Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs) [Time frame: Up to Week 24]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07658924 · CTCLTA001 · 82425050

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗