N/A
N=90
Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna
Cancer · Lentigo Maligna
Bottom Line
View on ClinicalTrials.gov: NCT00707174 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants — 27; 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Imiquimod Cream (Drug); Tazarotene Cream 0.1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants |
27; 29 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00707174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.