Phase 3
N=169
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
Superficial Basal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00189306 ↗Enrolled (actual)
169
Serious AEs
13.6%
Results posted
Nov 2008
Primary outcome: Primary: Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) — 119 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Imiquimod 5% cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Graceway Pharmaceuticals, LLC
- Primary completion
- Apr 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) |
119 | — |
| SECONDARY Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks |
159 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00189306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.