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

NCT07658924 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-06-22

No results posted yet for this study

Summary

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.

Conditions

  • Cutaneous T-Cell Lymphoma
  • Mycosis Fungoides (MF)

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.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-10-01
Completion
2027-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07658924 on ClinicalTrials.gov