EUCTR2017-001677-16-FR进行中（未招募）1 期
A randomized, double-blind, multi-centre, placebo-controlled, parallel-arm phase 2 trial to assess safety, efficacy and pharmacokinetics of CD11301 0.03% and 0.06% gel in the treatment of Cutaneous T-Cell Lymphoma (CTCL), stages IA, IB and IIA - Safety, efficacy and pharmacokinetics of CD11301 gel in early stage CTC
Galderma R&D SNC0 个研究点目标入组 112 人开始时间: 2018年1月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adults = 18 years of age at the screening visit.
- •2. Have a clinical diagnosis of cutaneous T cell lymphoma (CTCL) stage IA, IB, or IIA including documentation of a skin biopsy within the last three months with histological findings consistent with CTCL (Olsen et al, 2007).
- •3. For stage IIA, only subjects with a classification of N0 (No clinically abnormal peripheral lymph nodes) or N1 (clinically abnormal lymph node(s) histopathology Dutch grade 1 or NCI LN0-2) can be enrolled.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •1. Participation in previous studies with resiquimod.
- •2. Known or suspected allergies or sensitivities to any component of the resiquimod gel.
- •3. History of clinically meaningful allergic reactions to imiquimod.
- •4. History of autoimmune disease including (but not limited to) rheumatoid arthritis, autoimmune hepatitis, autoimmune thyroiditis, Sjögren syndrome, psoriasis, or systemic lupus erythematosus.
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