A Phase 2 interventional study of Benvitimod Cream and Placebo cream in Cutaneous T-Cell Lymphoma and Mycosis Fungoides (MF), sponsored by Peking University First Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Peking University First Hospital · Phase 2, Interventional, and Treatment
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.
337 studies on the registry are indexed under Lymphoma, T-Cell, Cutaneous; 61 are open to participants now.
This study's planned enrollment of 35 is close to the median of 33 across 275 interventional studies indexed under Lymphoma, T-Cell, Cutaneous.
Browse Lymphoma, T-Cell, Cutaneous studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The target lesion on one side of the body (left or right) randomly assigned to receive topical benvitimod cream.
Drug: Benvitimod Cream
The matching target lesion on the contralateral side of the body assigned to receive placebo cream.
Drug: Placebo 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.
Also known as: Tapinarof cream
A vehicle cream matching the appearance of benvitimod cream. Applied topically to the contralateral target lesion once daily for up to 24 weeks.
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
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University First Hospital