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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
|
|
プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage change in modified Severity-Weighted Assessment Tool (mSWAT) score
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CTCLTA001
- 82425050 (その他の助成金/資金番号：National Natural Science Foundation of China)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Benvitimod Creamの臨床試験
-
University of NottinghamNational Institute for Health Research, United Kingdom完了
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University of CalgaryHamilton Health Sciences Corporation募集