A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEDA Pharma GmbH & Co. KG
• Treatments: Imiquimod

Criteria

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.