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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
Results First Received: June 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Lentigo Maligna
Interventions: Drug: Imiquimod Cream
Drug: Tazarotene Cream 0.1%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Imiquimod Only

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.
Imiquimod and Tazarotene Combined

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.

Participant Flow:   Overall Study
    Imiquimod Only     Imiquimod and Tazarotene Combined  
STARTED     46     44  
COMPLETED     41     37  
NOT COMPLETED     5     7  
Adverse Event                 1                 6  
Withdrawal by Subject                 4                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Imiquimod Only

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.
Imiquimod and Tazarotene Combined

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.
Total Total of all reporting groups

Baseline Measures
    Imiquimod Only     Imiquimod and Tazarotene Combined     Total  
Number of Participants  
[units: participants]
 		  46     44     90  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     21     16     37  
>=65 years     25     28     53  
Age  
[units: years]
Mean ± Standard Deviation 		  67.87234  ± 13.07606     67.40909  ± 11.99286     67.64  ± 12.49655  
Gender  
[units: participants]
 		     
Female     11     13     24  
Male     35     31     66  
Region of Enrollment  
[units: participants]
 		     
United States     46     44     90  



  Outcome Measures

1.  Primary:   The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants   [ Time Frame: 24 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Glen Bowen, MD
Organization: University of Utah
phone: 801-581-0255
e-mail: glen.bown@hci.utah.edu


No publications provided by University of Utah

Publications automatically indexed to this study:


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