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

MEDA Pharma GmbH & Co. KG160 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Basal Cell Carcinoma

Interventions

imiquimodDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Univertätsklinik für Dermatologie und Venerologie

Magedeburg, Germany

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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