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Trial record 16 of 51 for:    tazarotene

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707174
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : August 20, 2012
Last Update Posted : July 31, 2013
Information provided by (Responsible Party):
University of Utah

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 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.

Condition or disease Intervention/treatment Phase
Cancer Lentigo Maligna Drug: Imiquimod Cream Drug: Tazarotene Cream 0.1% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Experimental: 2

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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00707174

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United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
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Principal Investigator: Glen Bowen, MD Huntsman Cancer Institute

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Utah Identifier: NCT00707174     History of Changes
Other Study ID Numbers: HCI13361
First Posted: June 30, 2008    Key Record Dates
Results First Posted: August 20, 2012
Last Update Posted: July 31, 2013
Last Verified: July 2013
Keywords provided by University of Utah:
Lentigo Maligna
Additional relevant MeSH terms:
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Hutchinson's Melanotic Freckle
Pigmentation Disorders
Skin Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nicotinic Acids
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Growth Substances