Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
- Registration Number
- NCT00189306
- Lead Sponsor
- Graceway Pharmaceuticals, LLC
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 169
- Have at least 1 previously untreated superficial basal cell carcinoma tumor
- Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm
- Evidence of clinically significant, unstable medical conditions
- Cannot have recent use of topical steroids or retinoids in the treatment area.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aldara Imiquimod 5% cream Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
- Primary Outcome Measures
Name Time Method Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) 5 years 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks 12 week posttreatment visit 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)
Trial Locations
- Locations (18)
Freemantle Dermatology
🇦🇺Fremantle, Western Australia, Australia
158 South Terrace
🇦🇺Perth, Western Australia, Australia
Skin Centre
🇦🇺Benowa, Queensland, Australia
Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
105 Fulham Road
🇦🇺Gulliver, Queensland, Australia
Colombo Mansions
🇳🇿Christchurch, New Zealand
Birthcare Building
🇳🇿Parnell, Auckland, New Zealand
Dermatology Practice
🇳🇿Christchurch, New Zealand
Skin Institute Limited
🇳🇿Takapuna, New Zealand
Austin & Repartriation Hospital
🇦🇺Heidelburg, Victoria, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
South East Dermatology Centre
🇦🇺Carina Heights, Queensland, Australia
103A Mountain Road
🇳🇿Epsom, Auckland, New Zealand
Medical Centre, Concord Hospital
🇦🇺Concord, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Western Hospital
🇦🇺Footscray, Victoria, Australia
Subiaco Clinic
🇦🇺Subiaco, Western Australia, Australia
Flinders Medical Center
🇦🇺Bedford Park, South Australia, Australia