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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

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ClinicalTrials.gov Identifier: NCT00707174
Recruitment Status : Completed
First Posted : June 30, 2008
Results First Posted : August 20, 2012
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cancer
Lentigo Maligna
Interventions Drug: Imiquimod Cream
Drug: Tazarotene Cream 0.1%
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Imiquimod Only Imiquimod and Tazarotene Combined
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 46 44
Completed 41 37
Not Completed 5 7
Reason Not Completed
Adverse Event             1             6
Withdrawal by Subject             4             1
Arm/Group Title Imiquimod Only Imiquimod and Tazarotene Combined Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 46 44 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  45.7%
16
  36.4%
37
  41.1%
>=65 years
25
  54.3%
28
  63.6%
53
  58.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 44 participants 90 participants
67.87234  (13.07606) 67.40909  (11.99286) 67.64  (12.49655)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 90 participants
Female
11
  23.9%
13
  29.5%
24
  26.7%
Male
35
  76.1%
31
  70.5%
66
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants 44 participants 90 participants
46 44 90
1.Primary Outcome
Title The Absence of Lentigo Maligna (LM) at the Time of Staged Excisions in Participants
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients from both groups were compared
Arm/Group Title Imiquimod Only Imiquimod and Tazarotene Combined
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 41 37
Measure Type: Number
Unit of Measure: participants
27 29
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Imiquimod Only Imiquimod and Tazarotene Combined
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Imiquimod Only Imiquimod and Tazarotene Combined
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Imiquimod Only Imiquimod and Tazarotene Combined
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/46 (0.00%)      0/44 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Imiquimod Only Imiquimod and Tazarotene Combined
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/46 (2.17%)      6/44 (13.64%)    
Skin and subcutaneous tissue disorders     
Inflammatory Response   1/46 (2.17%)  1 6/44 (13.64%)  6
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Glen Bowen, MD
Organization: University of Utah
Phone: 801-581-0255
EMail: glen.bown@hci.utah.edu
Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00707174     History of Changes
Other Study ID Numbers: HCI13361
First Submitted: June 25, 2008
First Posted: June 30, 2008
Results First Submitted: June 4, 2012
Results First Posted: August 20, 2012
Last Update Posted: July 31, 2013