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

NCT00707174 | Completed Results DMC

• 1 other identifier: HCI13361
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Lentigo Maligna

Keywords

Lentigo Maligna

Outcome Measures

Primary Outcomes (1)

• The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants

  Negative histologic margins for the imiquimod plus tazarotene group compared to the imiquimod only group.

  24 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

EXPERIMENTAL

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%

Interventions

Imiquimod Cream DRUG

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

1

Tazarotene Cream 0.1% DRUG

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (2)

• Hyde MA, Hadley ML, Tristani-Firouzi P, Goldgar D, Bowen GM. A randomized trial of the off-label use of imiquimod, 5%, cream with vs without tazarotene, 0.1%, gel for the treatment of lentigo maligna, followed by conservative staged excisions. Arch Dermatol. 2012 May;148(5):592-6. doi: 10.1001/archdermatol.2012.270.

  PMID: 22431716 DERIVED

• Ho PA, Kopecky KJ, Alonzo TA, Gerbing RB, Miller KL, Kuhn J, Zeng R, Ries RE, Raimondi SC, Hirsch BA, Oehler V, Hurwitz CA, Franklin JL, Gamis AS, Petersdorf SH, Anderson JE, Godwin JE, Reaman GH, Willman CL, Bernstein ID, Radich JP, Appelbaum FR, Stirewalt DL, Meshinchi S. Prognostic implications of the IDH1 synonymous SNP rs11554137 in pediatric and adult AML: a report from the Children's Oncology Group and SWOG. Blood. 2011 Oct 27;118(17):4561-6. doi: 10.1182/blood-2011-04-348888. Epub 2011 Aug 26.

  PMID: 21873548 DERIVED

MeSH Terms

Conditions

Neoplasms; Hutchinson's Melanotic Freckle

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas

Results Point of Contact

• Title: Glen Bowen, MD
• Organization: University of Utah

glen.bown@hci.utah.edu

801-581-0255

Study Officials

• Glen Bowen, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 30, 2008
• Study Start: March 1, 2005
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 31, 2013
• Results First Posted: August 20, 2012

Record last verified: 2013-07

Locations

US (1)