Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants
研究概览
简要总结
This study is designed as a randomized, prospective study to test the efficacy of imiquimod plus tazarotene in the treatment of LM. Eligible and consented patients will be randomized to one of two treatment groups: 1) topical imiquimod group, or 2) topical imiquimod combined with topical tazarotene group. All patients will undergo a staged surgical excision with rush permanent sections to confirm negative histologic margins. This will be followed by a surgical repair of the defect and long-term follow-up of five years to rule out recurrences. Both groups will have a polygonal excision using 2mm margins per stage.
详细描述
Objectives
The objectives of the study are:
- reduce the surgical morbidity of staged excisions which often require multiple stages of surgery in order to verify negative histologic margins
- investigate the addition of a topical retinoid, to our standard-of-care (topical imiquimod and staged-excision) and evaluate if there is improvement in efficacy
- to see if treatment of surrounding normal appearing skin with this combination of topical agents reduces recurrence rates compared to staged-excision. Our hypothesis is that the combination of topical agents will better treat the subclinical melanocytic atypia which can give rise to recurrences.
Primary endpoint:
The primary goal is a comparison of the number of stages required for negative histologic margins in the imiquimod plus tazarotene group compared to the imiquimod group. Tumors requiring 5 or more stages in will be combined into one category for data analysis. The Wilcoxon-Mann-Whitney test will be used for statistical comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •The study population will consist of eighty subjects who are 18 years or older and have a biopsy-proven lentigo maligna.
- •The subjects must have a LM that is in a location amenable to treatment with imiquimod, express a willingness and ability to comply with study requirements, and tolerate an outpatient surgical procedure.
- •All participants will sign consent documents prior to enrollment.
- •The typical age of patient that develops a LM is beyond the child-bearing range.
排除标准
- •In the event that a patient with a LM is pregnant, they will be excluded from the study.
- •inability to tolerate the surgical procedure
- •invasive melanoma
- •previous surgery on the site of interest
研究组 & 干预措施
1
Topical imiquimod group:
treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.
干预措施: Imiquimod Cream (Drug)
2
Topical imiquimod and topical tazarotene 0.1% cream group:
Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week.
干预措施: Tazarotene Cream 0.1% (Drug)
结局指标
主要结局
The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants
时间窗: 24 months
Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.
次要结局
未报告次要终点