Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna
Completed · Not applicable
Conditions studied: Cancer, Lentigo Maligna
In brief
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.
Key facts
- Study ID
- NCT00707174
- Run by
- University of Utah
- People needed
- 90
- Starts
- 2005-03-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2013-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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