Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

This study has been completed.
Sponsor:
Information provided by:
Graceway Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00189306
First received: September 13, 2005
Last updated: August 5, 2010
Last verified: August 2010
Results First Received: October 30, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Superficial Basal Cell Carcinoma
Intervention: Drug: Imiquimod 5% cream

  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
Study conducted in 18 study centers: 13 in Australia and 5 in New Zealand. The first subject entered this study on 27 March 2001; the last clinic visit was on 20 April 2007 and the last subject status determination (subject lost to follow-up) was on 27 April 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 169 subjects enrolled at 18 study centers in Australia and New Zealand.

Reporting Groups
  Description
Aldara Aldara (imiquimod) cream 5%

Participant Flow for 3 periods

Period 1:   Treatment Period
    Aldara  
STARTED     169  
COMPLETED     164 [1]
NOT COMPLETED     5  
Withdrawal by Subject                 2  
Adverse Event                 2  
Protocol Violation                 1  
[1] 5 subjects discontinued during treatment - 4 subjects returned for the Posttreatment Period

Period 2:   Posttreatment Period
    Aldara  
STARTED     169 [1]
COMPLETED     157 [2]
NOT COMPLETED     12  
Death                 1  
Withdrawal by Subject                 2  
Noncompliance                 1  
Target lesion excised                 1  
Protocol Violation                 1  
Evidence of Superficial Basal Cell Ca                 5  
Local skin reaction/sign                 1  
[1] 5 of the 169 discontinued, but 4 returned for the Posttreatment Period
[2] 11 subjects discontinued during the 12-week Posttreatment Period

Period 3:   Long-Term Follow-up
    Aldara  
STARTED     157  
COMPLETED     119  
NOT COMPLETED     38  
Adverse Event                 2  
Death                 4  
Withdrawal by Subject                 1  
Intercurrent disease                 2  
Lost to Follow-up                 9  
Evidence of Superficial Basal Cell Ca                 20  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Aldara Aldara (imiquimod) cream 5%

Baseline Measures
    Aldara  
Number of Participants  
[units: participants]
  169  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     130  
>=65 years     39  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 13  
Gender  
[units: participants]
 
Female     73  
Male     96  
Region of Enrollment  
[units: participants]
 
Australia     123  
New Zealand     46  



  Outcome Measures
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1.  Primary:   Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)   [ Time Frame: 5 years ]

2.  Secondary:   Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks   [ Time Frame: 12 week posttreatment visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Graceway Pharmaceuticals
phone: 267-984-0400
e-mail: jim.lee@gracewaypharma.com


Publications of Results:

Responsible Party: Medical Director, Graceway Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00189306     History of Changes
Other Study ID Numbers: 1413-IMIQ
Study First Received: September 13, 2005
Results First Received: October 30, 2008
Last Updated: August 5, 2010
Health Authority: United States: Food and Drug Administration