Back to resultsA Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma
Primary Purpose
Basal Cell Carcinoma
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
imiquimod
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Aldara, Superficial Basal Cell Carcinoma, Long-Term Study
Eligibility 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.
Sites / Locations
- Univertätsklinik für Dermatologie und Venerologie
Outcomes
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
Full Information
NCT ID
NCT00189241
First Posted
September 12, 2005
Last Updated
February 4, 2022
Sponsor
MEDA Pharma GmbH & Co. KG
1. Study Identification
Unique Protocol Identification Number
NCT00189241
Brief Title
A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma
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 Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
MEDA Pharma GmbH & Co. KG
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma
Keywords
Aldara, Superficial Basal Cell Carcinoma, Long-Term Study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
imiquimod
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univertätsklinik für Dermatologie und Venerologie
City
Magedeburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Effectiveness of Imiquimod 5% Cream in Superficial Basal Cell Carcinoma
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