Status:
COMPLETED
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
Lead Sponsor:
Graceway Pharmaceuticals, LLC
Conditions:
Superficial Basal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- Evidence of clinically significant, unstable medical conditions
- Cannot have recent use of topical steroids or retinoids in the treatment area.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00189306
Start Date
March 1 2001
End Date
April 1 2007
Last Update
August 10 2010
Active Locations (18)
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1
Medical Centre, Concord Hospital
Concord, New South Wales, Australia
2
Prince of Wales Hospital
Randwick, New South Wales, Australia
3
Skin Centre
Benowa, Queensland, Australia
4
South East Dermatology Centre
Carina Heights, Queensland, Australia