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

This study has been completed.

First Received: September 12, 2005 Last Updated: February 4, 2008 History of Changes

Sponsored by:	MEDA Pharma GmbH & Co. KG
Information provided by:	MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:	NCT00189241

Purpose

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	Intervention	Phase
Basal Cell Carcinoma	Drug: imiquimod	Phase III

Drug Information available for: S 26308

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by MEDA Pharma GmbH & Co. KG:

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

Estimated Enrollment:	160
Study Start Date:	February 2001

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189241

Locations

Germany
Univertätsklinik für Dermatologie und Venerologie
Magedeburg, Germany

Sponsors and Collaborators

MEDA Pharma GmbH & Co. KG

More Information

No publications provided

Study ID Numbers:	1412-IMIQ
Study First Received:	September 12, 2005
Last Updated:	February 4, 2008
ClinicalTrials.gov Identifier:	NCT00189241 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by MEDA Pharma GmbH & Co. KG:

Aldara
Superficial Basal Cell Carcinoma
Long-Term Study

Study placed in the following topic categories:

Immunologic Factors
Interferons
Adjuvants, Immunologic
Neoplasms, Basal Cell

Imiquimod
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Interferon Inducers
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Carcinoma, Basal Cell

Imiquimod
Pharmacologic Actions
Carcinoma
Neoplasms
Therapeutic Uses
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009