CompletedNot Applicable

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

United States90 participantsStarted 2005-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants

Timeframe: 24 months

Trial details

NCT IDNCT00707174

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-03

Results submitted2012-06-04