Status:
COMPLETED
Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna
Lead Sponsor:
University of Utah
Conditions:
Cancer
Lentigo Maligna
Eligibility:
All Genders
18+ years
Phase:
NA
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 tre...
Detailed Description
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. inve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00707174
Start Date
March 1 2005
End Date
March 1 2013
Last Update
July 31 2013
Active Locations (1)
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1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112