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

Sponsor

MEDA Pharma GmbH & Co. KG (Industry)

Overall Status

Completed

CT.gov ID

NCT00189241

Collaborator

(none)

160

Enrollment

Location

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Basal Cell Carcinoma	Drug: imiquimod	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Feb 1, 2001

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

Primary Outcome 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 Outcome 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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.