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SINS: Surgery vs Imiquimod for BCC
NCT00066872Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2002
- Countries
- 1
- Sponsor
- The Queen's Medical Center
- Modality
- Nucleic Acid-Directed Small Molecules, Irreversible Covalent Inhibitors, Metabolically Activated Prodrugs
- Drugs
- imiquimod
- Conditions
- basal cell carcinoma (BCC)
01
Overview
Phase 3, randomised, open-label trial of imiquimod in basal cell carcinoma (BCC) (2 arms), sponsored by The Queen's Medical Center. Primary endpoint: Absence of local recurrence at 3 years. Started Oct 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Imiquimod
Topical imiquimod 5% cream daily
Surgery
Surgical excision
03
Who it enrols
Patients with histologically confirmed primary nodular or superficial basal cell carcinoma in low-risk areas. Excludes patients with Gorlin's syndrome or morphoeic histology.
04
Endpoints
Primary
Absence of local recurrence
Secondary
Recurrence of basal cell cancer
Time to first recurrence
Aesthetic appearance of lesion site
Pain at lesion site
Cost effectiveness
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