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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aldara | Experimental | Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imiquimod 5% cream | Drug | Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 week posttreatment visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Lee, Dr. | Graceway Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Centre, Concord Hospital | Concord | New South Wales | Australia | |||
| Prince of Wales Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17034468 | Result | 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. | |
| 20666194 | Result |
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There were 169 subjects enrolled at 18 study centers in Australia and New Zealand.
Study conducted in 18 study centers: 13 in Australia and 5 in New Zealand. The first subject entered this study on 27 March 2001; the last clinic visit was on 20 April 2007 and the last subject status determination (subject lost to follow-up) was on 27 April 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aldara | Aldara (imiquimod) cream 5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| Randwick |
| New South Wales |
| Australia |
| Skin Centre | Benowa | Queensland | Australia |
| South East Dermatology Centre | Carina Heights | Queensland | Australia |
| 105 Fulham Road | Gulliver | Queensland | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Australia |
| Flinders Medical Center | Bedford Park | South Australia | Australia |
| Queen Elizabeth Hospital | Woodville | South Australia | Australia |
| Western Hospital | Footscray | Victoria | Australia |
| Austin & Repartriation Hospital | Heidelburg | Victoria | Australia |
| Freemantle Dermatology | Fremantle | Western Australia | Australia |
| 158 South Terrace | Perth | Western Australia | Australia |
| Subiaco Clinic | Subiaco | Western Australia | Australia |
| 103A Mountain Road | Epsom | Auckland | New Zealand |
| Birthcare Building | Parnell | Auckland | New Zealand |
| Colombo Mansions | Christchurch | New Zealand |
| Dermatology Practice | Christchurch | New Zealand |
| Skin Institute Limited | Takapuna | New Zealand |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Posttreatment Period |
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| Long-Term Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aldara | Aldara (imiquimod) cream 5% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required | Posted | Number | participants | 5 years |
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| ||||||||||||||||||||||||||
| Secondary | 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) | Two data sets were analyzed: intent-to-treat (ITT), consisting of all enrolled subjects and per-protocol (PP), consisting of ITT subjects who were free from major protocol violations, and who applied at least 60% of the doses required by the dosing regimen. | Posted | Number | participants | 12 week posttreatment visit |
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Adverse events were reported from post prestudy visit to throughout the treatment and posttreatment period (up to week 12). Serious Adverse Events were recorded throughout the follow-up period (up to the 60 month visit).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aldara | Aldara (imiquimod) cream 5% | 23 | 169 | 130 | 169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Embolism pulmonary | Vascular disorders | WHOART | Systematic Assessment |
| |
| Non-hodgkins lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
| |
| Excision BCC R forehead | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
| |
| Pulmonary carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
| |
| Bleeding post colonoscopy | Surgical and medical procedures | WHOART | Systematic Assessment |
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| Transient ischaemic attack | Vascular disorders | WHOART | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | WHOART | Systematic Assessment |
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| Cholecyctitis | Hepatobiliary disorders | WHOART | Systematic Assessment |
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| Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
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| Breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
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| Colon carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
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| Carpal tunnel syndrome | General disorders | WHOART | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
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| Goitre | Endocrine disorders | WHOART | Systematic Assessment |
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| Bladder carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
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| Prostatic disorder | Reproductive system and breast disorders | WHOART | Systematic Assessment |
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| Acute renal failure | Renal and urinary disorders | WHOART | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | WHOART | Systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | WHOART | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | WHOART | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
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| Myocardial ischemia | Cardiac disorders | WHOART | Systematic Assessment |
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| Chest pain | General disorders | WHOART | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Chronic renal failure | Renal and urinary disorders | WHOART | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site reaction | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
| |
| Headache | Nervous system disorders | WHOART | Systematic Assessment |
| |
| Pain | General disorders | WHOART | Systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Graceway Pharmaceuticals | 267-984-0400 | jim.lee@gracewaypharma.com |
| ID | Term |
|---|---|
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Target lesion excised |
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| Protocol Violation |
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| Evidence of Superficial Basal Cell Ca |
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| Local skin reaction/sign |
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| Intercurrent disease |
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| Lost to Follow-up |
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| Evidence of Superficial Basal Cell Ca |
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