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

September 13, 2005
August 5, 2010
March 2001
April 2007   (final data collection date for primary outcome measure)
Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.
Evaluate the long-term sustained clearance rate of BCC
Complete list of historical versions of study NCT00189306 on ClinicalTrials.gov Archive Site
Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks [ Time Frame: 12 week posttreatment visit ] [ Designated as safety issue: No ]
Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)
Safety and Cosmetic outcome of treatment of BCC
Not Provided
Not Provided
 
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma

An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Superficial Basal Cell Carcinoma
Drug: Imiquimod 5% cream
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
Other Name: Aldara (imiquimod) 5% cream - 250 mg / packet
Experimental: Aldara
Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
Intervention: Drug: Imiquimod 5% cream

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have at least 1 previously untreated superficial basal cell carcinoma tumor
  • Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm

Exclusion Criteria:

  • Evidence of clinically significant, unstable medical conditions
  • Cannot have recent use of topical steroids or retinoids in the treatment area.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   New Zealand
 
NCT00189306
1413-IMIQ
No
Medical Director, Graceway Pharmaceuticals
Graceway Pharmaceuticals, LLC
Not Provided
Study Director: Jim Lee, Dr. Graceway Pharmaceuticals
Graceway Pharmaceuticals, LLC
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP