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

NCT00707174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-07-31

Study results available
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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.

Conditions

Interventions

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

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.

Sponsors & Collaborators

Principal Investigators

  • Glen Bowen, MD · Huntsman Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707174 on ClinicalTrials.gov