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

Meda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Basal Cell Carcinoma

Treatments: Drug: imiquimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189241

1412-IMIQ

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)