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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2007-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Basal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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imiquimod

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No