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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00707174
First received: June 25, 2008
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Cancer
Lentigo Maligna
 Drug: Imiquimod Cream
Drug: Tazarotene Cream 0.1%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination Therapy With Imiquimod Cream 5% and Tazarotene Cream 0.1% for the Treatment of Lentigo Maligna

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.


Enrollment: 90
Study Start Date: March 2005
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707174

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

No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00707174     History of Changes
Other Study ID Numbers: HCI13361
Study First Received: June 25, 2008
Results First Received: June 4, 2012
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Lentigo Maligna

Additional relevant MeSH terms:
Lentigo
Hutchinson's Melanotic Freckle
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Imiquimod
 Tazarotene
Nicotinic Acids
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers
Keratolytic Agents
Dermatologic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013