Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Superficial Basal Cell Carcinoma

Intervention / Treatment
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* Drug: Imiquimod 5% cream


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aldara<br>Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks | Drug: Imiquimod 5% cream<br>* Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks<br>* Other names: Aldara (imiquimod) 5% cream - 250 mg / packet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks | 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) | 12 week posttreatment visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial Basal Cell Carcinoma, Aldara