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

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ClinicalTrials.gov Identifier: NCT00189241
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 26, 2010
Sponsor:
Information provided by:
MEDA Pharma GmbH & Co. KG

September 12, 2005
September 19, 2005
August 26, 2010
February 2001
February 2007   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00189241 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma
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
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
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Basal Cell Carcinoma
Drug: imiquimod
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
Same as current
February 2007
February 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00189241
1412-IMIQ
Not Provided
Not Provided
Not Provided
Not Provided
MEDA Pharma GmbH & Co. KG
Not Provided
Not Provided
MEDA Pharma GmbH & Co. KG
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP