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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00189306
Registration number
NCT00189306
Ethics application status
Date submitted
13/09/2005
Date registered
19/09/2005
Date last updated
10/08/2010
Titles & IDs
Public title
Open-label Study to Evaluate Clearance of Superficial Basal Cell Carcinoma After Use of Imiquimod 5% Cream
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Scientific 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
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Secondary ID [1]
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1413-IMIQ
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Superficial Basal Cell Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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0
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Imiquimod 5% cream
Experimental: Aldara - Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
Treatment: Drugs: Imiquimod 5% cream
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC)
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Assessment method [1]
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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.
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks
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Assessment method [1]
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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)
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Timepoint [1]
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12 week posttreatment visit
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Evidence of clinically significant, unstable medical conditions
- Cannot have recent use of topical steroids or retinoids in the treatment area.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2007
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Sample size
Target
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Accrual to date
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Final
169
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Medical Centre, Concord Hospital - Concord
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Recruitment hospital [2]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [3]
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Skin Centre - Benowa
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Recruitment hospital [4]
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South East Dermatology Centre - Carina Heights
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Recruitment hospital [5]
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105 Fulham Road - Gulliver
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Recruitment hospital [6]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [7]
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Flinders Medical Center - Bedford Park
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Recruitment hospital [8]
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Queen Elizabeth Hospital - Woodville
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Recruitment hospital [9]
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Western Hospital - Footscray
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Recruitment hospital [10]
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Austin & Repartriation Hospital - Heidelburg
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Recruitment hospital [11]
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Freemantle Dermatology - Fremantle
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Recruitment hospital [12]
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158 South Terrace - Perth
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Recruitment hospital [13]
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Subiaco Clinic - Subiaco
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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- Randwick
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Recruitment postcode(s) [3]
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- Benowa
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Recruitment postcode(s) [4]
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- Carina Heights
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Recruitment postcode(s) [5]
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- Gulliver
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Recruitment postcode(s) [6]
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- Woolloongabba
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Recruitment postcode(s) [7]
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- Bedford Park
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Recruitment postcode(s) [8]
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- Woodville
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Recruitment postcode(s) [9]
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- Footscray
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Recruitment postcode(s) [10]
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- Heidelburg
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Recruitment postcode(s) [11]
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- Fremantle
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Recruitment postcode(s) [12]
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- Perth
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Recruitment postcode(s) [13]
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- Subiaco
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Takapuna
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Graceway Pharmaceuticals, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00189306
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jim Lee, Dr.
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Address
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Graceway Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00189306
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