We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00189306
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : November 26, 2008
Last Update Posted : August 10, 2010
Information provided by:
Graceway Pharmaceuticals, LLC

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Superficial Basal Cell Carcinoma
Intervention: Drug: Imiquimod 5% cream

  Participant Flow

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
Aldara Aldara (imiquimod) cream 5%

Participant Flow for 3 periods

Period 1:   Treatment Period
STARTED   169 
COMPLETED   164 [1] 
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
STARTED   169 [1] 
COMPLETED   157 [2] 
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
STARTED   157 
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

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.
No text entered.

Reporting Groups
Aldara Aldara (imiquimod) cream 5%

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   130 
>=65 years   39 
[Units: Years]
Mean (Standard Deviation)
 57  (13) 
[Units: Participants]
Female   73 
Male   96 
Region of Enrollment 
[Units: Participants]
Australia   123 
New Zealand   46 

  Outcome Measures

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

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
No text entered.

  More Information

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
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: October 30, 2008
Results First Posted: November 26, 2008
Last Update Posted: August 10, 2010