Title
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
Phase
Phase 3Lead Sponsor
GracewayStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Superficial Basal Cell CarcinomaIntervention/Treatment
imiquimod ...Study Participants
169An 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.
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
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.
| Event Type | Organ System | Event Term | Aldara |
|---|
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.
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)
