At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 169 enrolled
Drug / intervention
Imiquimod 5% creamdrug
Likely dose
Imiquimod 5% cream 250 mg/packet applied once daily 7 days per week for 6 weeksAI-extracted
Key inclusion· 2
- ✓At least 1 previously untreated superficial basal cell carcinoma tumor
- ✓Minimum tumor size 0.5 cm² and maximum diameter of 2.0 cm
Key exclusion· 2
- ✕Evidence of clinically significant, unstable medical conditions
- ✕Recent use of topical steroids or retinoids in the treatment area
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Imiquimod 5% cream for Superficial Basal Cell Carcinoma. Completed, enrolled 169 participants across 18 sites in 2 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuperficial Basal Cell Carcinoma
CountriesAustralia, New Zealand
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2001
First PostedSep 2005
Primary CompletionApr 2007
TodayJul 2026
First PostedSep 19, 2005
Enrollment StartMar 1, 2001
Primary CompletionApr 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.8 years ago
Interventions
Imiquimod 5% creamdrug
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks