Health TrialsbyHealthPanel

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

ConditionsCutaneous T-Cell LymphomaMycosis Fungoides (MF)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Benvitimod treated sideExperimental treatment 1 intervention
Group B: Placebo treated sidePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: