Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma (BEST-CTCL)
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.
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Benvitimod treated side
The target lesion on one side of the body (left or right) randomly assigned to receive topical 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.
Andre navne:
|
|
Placebo komparator: Placebo treated side
The matching target lesion on the contralateral side of the body assigned to receive 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score
Tidsramme: 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.
|
Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
|
|
Change in Pruritus Visual Analogue Scale (VAS) score
Tidsramme: 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.
|
Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Tidsramme: Up to Week 24
|
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.
|
Up to Week 24
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CTCLTA001
- 82425050 (Andet bevillings-/finansieringsnummer: National Natural Science Foundation of China)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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