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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
1413-IMIQ
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Superficial Basal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
12 week posttreatment visit

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Evidence of clinically significant, unstable medical conditions

- Cannot have recent use of topical steroids or retinoids in the treatment area.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Medical Centre, Concord Hospital - Concord
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Skin Centre - Benowa
Recruitment hospital [4] 0 0
South East Dermatology Centre - Carina Heights
Recruitment hospital [5] 0 0
105 Fulham Road - Gulliver
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [8] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment hospital [9] 0 0
Western Hospital - Footscray
Recruitment hospital [10] 0 0
Austin & Repartriation Hospital - Heidelburg
Recruitment hospital [11] 0 0
Freemantle Dermatology - Fremantle
Recruitment hospital [12] 0 0
158 South Terrace - Perth
Recruitment hospital [13] 0 0
Subiaco Clinic - Subiaco
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Randwick
Recruitment postcode(s) [3] 0 0
- Benowa
Recruitment postcode(s) [4] 0 0
- Carina Heights
Recruitment postcode(s) [5] 0 0
- Gulliver
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment postcode(s) [7] 0 0
- Bedford Park
Recruitment postcode(s) [8] 0 0
- Woodville
Recruitment postcode(s) [9] 0 0
- Footscray
Recruitment postcode(s) [10] 0 0
- Heidelburg
Recruitment postcode(s) [11] 0 0
- Fremantle
Recruitment postcode(s) [12] 0 0
- Perth
Recruitment postcode(s) [13] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Takapuna

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Graceway Pharmaceuticals, LLC
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00189306
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jim Lee, Dr.
Address 0 0
Graceway Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications