NCT04809662终止不适用
Comparing Immune Responses to Topical Imiquimod
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Immune response
研究概览
简要总结
The study is a basic science research study that is designed to characterize and compare the immune response in individuals who are designated as ABO blood group secretors, meaning they have a functional copy of the FUT2 gene versus those patients who are designated ABO non-secretors after application of topical imiquimod to these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals between 18 to 85 years of age
- •Patients with a diagnosis that will result in treatment with imiquimod as standard of care, specifically actinic keratosis
排除标准
- •Younger than 18 years or older than 85 years.
- •History of hypersensitivity/ allergic reaction or adverse reaction to imiquimod
- •Individuals with a diagnostic biopsy and supportive histology of a cutaneous immune-mediated disease (e.g. psoriasis and mycosis fungoides, etc.) or diseases of the hematopoietic system, liver and the gastrointestinal tract (e.g. aplastic anemia, Crohn's disease, Ulcerative Colitis, Primary Sclerosing Cholangitis (PSC), Primary Biliary Cirrhosis, acute and chronic graft versus host disease (GVHD)).
- •Individuals with autoantibodies plus objective evidence of end organ damage related to a cutaneous immune-mediated disease (e.g. psoriasis and mycosis fungoides, etc.) or diseases of the hematopoietic system, liver and the gastrointestinal tract (e.g. aplastic anemia, Crohn's disease, Ulcerative Colitis, Primary Sclerosing Cholangitis (PSC), Primary Biliary Cirrhosis, acute and chronic graft versus host disease (GVHD)).
- •Individuals with a history of serious infection within the last 6 months.
- •Individuals with tuberculosis, HIV, or hepatitis B, or C.
- •Patients unable to provide consent
- •Incarcerated individuals
研究组 & 干预措施
Main cohort
This is a split-body study, with patients acting as their own controls between lesional and nonlesional skin. All patients will apply imiquimod.
干预措施: Imiquimod (Drug)
结局指标
主要结局
Immune response
时间窗: 5 years
RNA sequencing of patients to gauge immune response as measured by expression of key inflammatory cytokines related to TLR7 response generated by imiquimod.
次要结局
- Monitoring(1 year)
- Flow cytometry(3 years)
- Immunohistochemistry(3 years)
研究者
研究点 (1)
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