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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Imiquimod; Nicotinic Acids; Tazarotene

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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