NCT00779896Unknown1 期
Tazarotene 0.1% Cream For the Treatment of Cutaneous T-Cell Lymphoma: A Prospective Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Partial response (PR) is defined as some improvement (25%-50%);significant evidence of disease remains or disease has not changed from baseline condition (<25%);no new clinically abnormal(>1.5 cm)lymph nodes,<25% progression of existence
研究概览
简要总结
This is an open label, prospective study to evaluate therapeutic potential of Tazarotene 0.1% cream for the treatment of Stage I-IIA CTCL. Patients with Stage I-IIA disease are enrolled into the study. Tazarotene will be used for up to 24 weeks and patients will be followed for up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Stage I-IIA CTCL must be at least 18 years of age with a skin biopsy prior to enrolment confirming the diagnosis of mycosis fungoides.
排除标准
- •Patients with Stage >IIA CTCL at the time of enrolment
- •Women who are pregnant or planning to get pregnant, or unable/unwilling to use adequate contraception
- •Patients who were treated with topical retinoid therapy in the past 3 months
- •Patients who received any systemic CTCL therapy or systemic corticosteroid therapy within 30 days of the study start date
- •Patients who were treated with systemic isotretinoin or bexarotene within 3 months prior to the study start date, systemic acitretin within 2 years prior to study start date
结局指标
主要结局
Partial response (PR) is defined as some improvement (25%-50%);significant evidence of disease remains or disease has not changed from baseline condition (<25%);no new clinically abnormal(>1.5 cm)lymph nodes,<25% progression of existence
次要结局
未报告次要终点
研究者
研究点 (2)
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