Clinical Trial: Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna

Brief Summary: 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.

Detailed Summary:

Objectives

The objectives of the study are:

1. reduce the surgical morbidity of staged excisions which often require multiple stages of surgery in order to verify negative histologic margins
2. 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
3. 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.

Secondary endpoints:

1. Comparison of the surgical defect size (mm2) between the study groups. The difference in area between the entire surgical defect and the original tumor (as recorded on transparent plastic) will be calculated for each patient and used as an endpoint.
2. Comparison of skin inflammation between the study groups. Skin inflammation will be recorded as an ordered categorical variable with four categories (0-3) as described in Section 5.
3. Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.