Clinical trial · Interventional
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
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
NCT00189306CI-TRIAL-00003763completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Superficial Basal Cell Carcinoma | Superficial Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod 5% cream | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aldara
- description
- Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
- interventionNames
- Drug: Imiquimod 5% cream
Primary outcomes (1)
- measure
- Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
- timeFrame
- 5 years
- description
- 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 outcomes (1)
- measure
- Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTQuirk C, Gebauer K, Owens M, Stampone P. Two-year interim results from a 5-year study evaluating clinical recurrence of superficial basal cell carcinoma after treatment with imiquimod 5% cream daily for 6 weeks. Australas J Dermatol. 2006 Nov;47(4):258-65. doi: 10.1111/j.1440-0960.2006.00313.x. PMID 17034468
- RESULTQuirk C, Gebauer K, De'Ambrosis B, Slade HB, Meng TC. Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study. Cutis. 2010 Jun;85(6):318-24. PMID 20666194