Cutaneous T-Cell LymphomaPhase 2BEST-CTCLNCT07658924
Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma
A Phase 2 study testing Benvitimod Cream in people with Cutaneous T-Cell Lymphoma and Mycosis Fungoides (MF), run by Peking University First Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous T-Cell Lymphoma, Mycosis Fungoides (MF)
- What is being tested?
- Benvitimod Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Evaluation of the Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma
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.
Read more
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)
- Being tested
- Benvitimod Cream, Placebo cream
- Keywords
- Benvitimod, Tapinarof, Topical Therapy
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benvitimod CreamDrug
Also called Tapinarof 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.
Placebo creamDrug
A vehicle cream matching the appearance of benvitimod cream. Applied topically to the contralateral target lesion once daily for up to 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Benvitimod treated side | Experimental | The target lesion on one side of the body (left or right) randomly assigned to receive topical benvitimod cream. Receives: Drug: Benvitimod Cream |
| Placebo treated side | Placebo comparator | The matching target lesion on the contralateral side of the body assigned to receive placebo cream. Receives: Drug: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous T-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang WANG, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658924
- Sponsor's protocol ID
- CTCLTA001
- Other IDs
- 82425050
- Acronym
- BEST-CTCL
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07658924
- Acronym / sponsor ID
- BEST-CTCL / CTCLTA001
- Conditions
- Cutaneous T-Cell Lymphoma, Mycosis Fungoides (MF)
- Keywords
- Benvitimod, Tapinarof, Topical Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benvitimod treated side | Experimental | Drug: Benvitimod CreamThe target lesion on one side of the body (left or right) randomly assigned to receive topical benvitimod cream. |
| Placebo treated side | Placebo comparator | Drug: Placebo creamThe matching target lesion on the contralateral side of the body assigned to receive placebo cream. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benvitimod CreamAlso: Tapinarof creamApplied 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 | Benvitimod treated side |
| Placebo creamA vehicle cream matching the appearance of benvitimod cream. Applied topically to the contralateral target lesion once daily for up to 24 weeks. | Drug | Placebo treated side |
Primary outcome
Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
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.
Change in Pruritus Visual Analogue Scale (VAS) score
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
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.
1 secondary outcome
Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Time frame: Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benvitimod Cream in people with Cutaneous T-Cell Lymphoma and Mycosis Fungoides (MF), run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score (time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.