Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna
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|ClinicalTrials.gov Identifier: NCT00707174|
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : August 20, 2012
Last Update Posted : July 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cancer Lentigo Maligna||Drug: Imiquimod Cream Drug: Tazarotene Cream 0.1%||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Active Comparator: 1
Topical imiquimod group:
treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.
Drug: Imiquimod Cream
Our current standard-of-care is to use imiquimod daily for 12 weeks followed by a staged-excision with 2mm margins per stage. These margins are justified because the standard-of care for lentigo maligna is continuing to evolve
Topical imiquimod and topical tazarotene 0.1% cream group:
Patients randomized to this group will undergo an identical treatment protocol as the topical imiquimod group with the addition of topical tazarotene 0.1% cream on Saturday and Sunday of each week.
Drug: Tazarotene Cream 0.1%
Tazarotene is a topical retinoid cream that is commonly used to treat psoriasis and acne. It is known to help keratinocyte maturation and thinning of the stratum corneum (top layer of the epidermis). The stratum corneum functions as the primary barrier to the penetration of topical medications. The penetration of topical medications can be enhanced if the stratum corneum is thinned. We believe that the treatment of lentigo maligna with imiquimod, and staged-excision, will be improved by the addition of tazarotene cream.
- The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants [ Time Frame: 24 months ]Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707174
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Glen Bowen, MD||Huntsman Cancer Institute|