Back to resultsOpen-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
Primary Purpose
Superficial Basal Cell Carcinoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Imiquimod 5% cream
Sponsored by
About this trial
This is an interventional treatment trial for Superficial Basal Cell Carcinoma focused on measuring Superficial Basal Cell Carcinoma, Aldara
Eligibility Criteria
Inclusion Criteria: Have at least 1 previously untreated superficial basal cell carcinoma tumor Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm Exclusion Criteria: Evidence of clinically significant, unstable medical conditions Cannot have recent use of topical steroids or retinoids in the treatment area.
Sites / Locations
- Medical Centre, Concord Hospital
- Prince of Wales Hospital
- Skin Centre
- South East Dermatology Centre
- 105 Fulham Road
- Princess Alexandra Hospital
- Flinders Medical Center
- Queen Elizabeth Hospital
- Western Hospital
- Austin & Repartriation Hospital
- Freemantle Dermatology
- 158 South Terrace
- Subiaco Clinic
- 103A Mountain Road
- Birthcare Building
- Colombo Mansions
- Dermatology Practice
- Skin Institute Limited
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aldara
Arm Description
Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
Outcomes
Primary Outcome Measures
Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.
Secondary Outcome Measures
Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks
Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)
Full Information
NCT ID
NCT00189306
First Posted
September 13, 2005
Last Updated
August 5, 2010
Sponsor
Graceway Pharmaceuticals, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00189306
Brief Title
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
Official Title
An Open-label Study to Evaluate the Safety and Long-Term Clinical Efficacy of Imiquimod 5% Cream Applied Once Daily 7 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
March 2001 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Graceway Pharmaceuticals, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.
Detailed Description
Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Basal Cell Carcinoma
Keywords
Superficial Basal Cell Carcinoma, Aldara
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aldara
Arm Type
Experimental
Arm Description
Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Imiquimod 5% cream
Other Intervention Name(s)
Aldara (imiquimod) 5% cream - 250 mg / packet
Intervention Description
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
Description
Number of participants clinically clear of superficial basal cell carcinoma at the treated target tumor site at the 12-week posttreatment visit (ie, initial clearance rate) who remain clear during a 5 year follow-up period.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks
Description
Number of participants cleared at 12 weeks(the number of subjects with no clinical evidence of superficial basal cell carcinoma at the target tumor site at the 12-week posttreatment visit)
Time Frame
12 week posttreatment visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have at least 1 previously untreated superficial basal cell carcinoma tumor
Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm
Exclusion Criteria:
Evidence of clinically significant, unstable medical conditions
Cannot have recent use of topical steroids or retinoids in the treatment area.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jim Lee, Dr.
Organizational Affiliation
Graceway Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Medical Centre, Concord Hospital
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Skin Centre
City
Benowa
State/Province
Queensland
Country
Australia
Facility Name
South East Dermatology Centre
City
Carina Heights
State/Province
Queensland
Country
Australia
Facility Name
105 Fulham Road
City
Gulliver
State/Province
Queensland
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Flinders Medical Center
City
Bedford Park
State/Province
South Australia
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
Country
Australia
Facility Name
Western Hospital
City
Footscray
State/Province
Victoria
Country
Australia
Facility Name
Austin & Repartriation Hospital
City
Heidelburg
State/Province
Victoria
Country
Australia
Facility Name
Freemantle Dermatology
City
Fremantle
State/Province
Western Australia
Country
Australia
Facility Name
158 South Terrace
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Subiaco Clinic
City
Subiaco
State/Province
Western Australia
Country
Australia
Facility Name
103A Mountain Road
City
Epsom
State/Province
Auckland
Country
New Zealand
Facility Name
Birthcare Building
City
Parnell
State/Province
Auckland
Country
New Zealand
Facility Name
Colombo Mansions
City
Christchurch
Country
New Zealand
Facility Name
Dermatology Practice
City
Christchurch
Country
New Zealand
Facility Name
Skin Institute Limited
City
Takapuna
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
17034468
Citation
Quirk C, Gebauer K, Owens M, Stampone P. Two-year interim results from a 5-year study evaluating clinical recurrence of superficial basal cell carcinoma after treatment with imiquimod 5% cream daily for 6 weeks. Australas J Dermatol. 2006 Nov;47(4):258-65. doi: 10.1111/j.1440-0960.2006.00313.x.
Results Reference
result
PubMed Identifier
20666194
Citation
Quirk C, Gebauer K, De'Ambrosis B, Slade HB, Meng TC. Sustained clearance of superficial basal cell carcinomas treated with imiquimod cream 5%: results of a prospective 5-year study. Cutis. 2010 Jun;85(6):318-24.
Results Reference
result
Learn more about this trial
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
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