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
18 Years
N/A
Both
Superficial Basal Cell Carcinoma
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
Outcome Description:
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.
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Jim Lee, Dr.
Investigator Role:
Study Director
Investigator Affiliation:
Graceway Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
1413-IMIQ
NCT ID:
NCT00189306
Start Date:
March 2001
Completion Date:
April 2007
Related Keywords:
- Superficial Basal Cell Carcinoma
- Superficial Basal Cell Carcinoma
- Aldara
- Carcinoma
- Carcinoma, Basal Cell
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