Official Title: “An Open-Label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 5 Days Per Week for 6 Weeks in the Treatment of Superficial Basal Cell Carcinoma”

The purpose of this study is to evaluate the long-term sustained clearance rate of superficial basal cell carcinoma during a 5 year period following treatment with imiquimod

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: imiquimod

Primary Measures

• To evaluate the long-term sustained clearance rate, defined as the proportion of subjects who are clinically clear of sBCC at the treated sBCC target tumour site at the 12 week posttreatment visit and remain clear during the 5 year follow-up period.

Secondary Measures

• To evaluate the safety and cosmetic outcome of once daily 5 days per week dosing for 6 weeks with imiquimod 5% cream in the treatment of sBCC

Inclusion Criteria:

• Have one superficial BCC - primary tumour
• Minimum tumour area of 0.5cm2, maximum diameter of 2.0cm.
• If female and of child bearing potential, negative pregnancy test and willing to use medically acceptable method of contraception.

Exclusion Criteria:

• Evidence of clinically significant, unstable medical conditions.
• Evidence of Gorlin syndrome, metastatic tumour or tumour with high probability of metastatic spread, have or have had within last 5 years other malignant cancers of the skin at target tumour site.
• Have received defined treatments in tumour site or surrounding area.
• Any dermatological disease in the target tumour site or surrounding area.
• Have had a systemic bacterial or viral infection within 2 weeks prior to study initiation.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: MEDA Pharma GmbH & Co. KG

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00189241

Study ID Number: 1412-IMIQ

ClinicalTrials.gov Identifier: NCT00189241

Health Authority: Germany: Federal Institute for Drugs and Medical Devices