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

This study has been completed.
Sponsor:
Information provided by:
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00189241
First received: September 12, 2005
Last updated: August 25, 2010
Last verified: August 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Imiquimod
U.S. FDA Resources

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
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  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

ClinicalTrials.gov Identifier: NCT00189241     History of Changes
Other Study ID Numbers: 1412-IMIQ
Study First Received: September 12, 2005
Last Updated: August 25, 2010
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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Imiquimod
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on May 16, 2013