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

NCT07658924 | Not Yet Recruiting Phase 2

• 2 other identifiers: CTCLTA00182425050
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

Benvitimod; Tapinarof; Topical Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24

Secondary Outcomes (1)

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

  Up to Week 24

Study Arms (2)

Benvitimod treated side

EXPERIMENTAL

The target lesion on one side of the body (left or right) randomly assigned to receive topical benvitimod cream.

Drug: Benvitimod Cream

Placebo treated side

PLACEBO COMPARATOR

The matching target lesion on the contralateral side of the body assigned to receive placebo cream.

Drug: Placebo cream

Interventions

Benvitimod Cream DRUG

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.

Also known as: Tapinarof cream

Benvitimod treated side

Placebo cream DRUG

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

Placebo treated side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share