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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189241
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 26, 2010
Information provided by:
MEDA Pharma GmbH & Co. KG

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 Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
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 : February 2001
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Imiquimod

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189241

Univertätsklinik für Dermatologie und Venerologie
Magedeburg, Germany
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG Identifier: NCT00189241     History of Changes
Other Study ID Numbers: 1412-IMIQ
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 26, 2010
Last Verified: August 2010

Keywords provided by MEDA Pharma GmbH & Co. KG:
Superficial Basal Cell Carcinoma
Long-Term Study

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