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.
연구 개요
연구 유형
등록 (추정된)
단계
- 2 단계
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
|
위약 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CTCLTA001
- 82425050 (기타 보조금/기금 번호: National Natural Science Foundation of China)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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