Phase III Trial of 6 Weeks of Imiquimod for the Treatment of Bowens Disease of the Head and Neck. Outcome is Histologic Clearance at 14 Weeks.
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- histologic clearance of Bowens disease in treated versus placebo group
研究概览
简要总结
- Double blinded, randomized, placebo controlled trial of imiquimod for the treatment of histologically proven Bowens disease of the head and neck.
- Null hypothesis: No difference in histologic clearance rates of patients with head or neck Bowens treated with imiquimod versus placebo.
- Outcome: Histologic clearance of Bowens disease at T=14 weeks.
详细描述
Interventional study Enrolling
Inclusion criteria: Military beneficiaries with histologically proven Bowens disease, located on the head and neck, defined as any area superior to the clavicle and anterior to the posterior triangle of the neck
Exclusion Criteria:
-
Previous treatment of biopsied lesion Recurrent lesions from previous biopsy-proven Bowen's disease
-
Patients younger than 18 years of age
-
Pregnancy
-
Immunosuppression, including HIV, transplant patients on immune suppressive medications, cancer patients on chemotherapy, and hematologic malignancies (e.g., lymphoma, leukemia)
-
Mucous membrane involvement
-
Lesions larger than 2 cm
-
Methods: Pts randomized to treatment group (6 weeks of Mon-Friday Imiquimod to Bowens site) or vehicle group (same treatment regimen). All patients undergo surgical excision (Mohs or simple excision) of site where disease is either visible or was present and tissue examined for histologic evidence of residual Bowens disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Histologic diagnosis of Bowen's disease (squamous cell carcinoma in situ), defined as full-thickness keratinocyte atypia and architectural disorder limited to the epidermis, with or without involvement of the follicular unit
- •Located on the head and neck, defined as any area superior to the clavicle and anterior to the posterior triangle of the neck
- •Primary Bowen's disease (first diagnosis)
排除标准
- •Previous treatment of biopsied lesion
- •Recurrent lesions from previous biopsy-proven Bowen's disease
- •Patients younger than 18 years of age
- •Pregnancy
- •Immunosuppression, including HIV, transplant patients on immune suppressive medications, cancer patients on chemotherapy, and hematologic malignancies (e.g., lymphoma, leukemia)
- •Mucous membrane involvement
- •Lesions larger than 2 cm
结局指标
主要结局
histologic clearance of Bowens disease in treated versus placebo group
时间窗: 14 weeks
次要结局
未报告次要终点