Superficial Basal Cell Carcinoma
Conditions
Keywords
Superficial Basal Cell Carcinoma, Aldara
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.
Interventions
Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks
Sponsors
Graceway Pharmaceuticals, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) | 5 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks | 12 week posttreatment visit | 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) |
Countries
Australia, New Zealand
Participant flow
Recruitment details
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.
Pre-assignment details
There were 169 subjects enrolled at 18 study centers in Australia and New Zealand.
Participants by arm
| Arm | Count |
|---|---|
| Aldara Aldara (imiquimod) cream 5% | 169 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Long-Term Follow-up | Adverse Event | 2 |
| Long-Term Follow-up | Death | 4 |
| Long-Term Follow-up | Evidence of Superficial Basal Cell Ca | 20 |
| Long-Term Follow-up | Intercurrent disease | 2 |
| Long-Term Follow-up | Lost to Follow-up | 9 |
| Long-Term Follow-up | Withdrawal by Subject | 1 |
| Posttreatment Period | Death | 1 |
| Posttreatment Period | Evidence of Superficial Basal Cell Ca | 5 |
| Posttreatment Period | Local skin reaction/sign | 1 |
| Posttreatment Period | Noncompliance | 1 |
| Posttreatment Period | Protocol Violation | 1 |
| Posttreatment Period | Target lesion excised | 1 |
| Posttreatment Period | Withdrawal by Subject | 2 |
| Treatment Period | Adverse Event | 2 |
| Treatment Period | Protocol Violation | 1 |
| Treatment Period | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Aldara |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 39 Participants |
| Age, Categorical Between 18 and 65 years | 130 Participants |
| Age Continuous | 57 years STANDARD_DEVIATION 13 |
| Region of Enrollment Australia | 123 participants |
| Region of Enrollment New Zealand | 46 participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 96 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 130 / 169 |
| serious Total, serious adverse events | 23 / 169 |
Outcome results
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.
Time frame: 5 years
Population: 2 data sets: ITT - all enrolled subjects and PP - ITT subjects free from major protocol violations and applied at least 60% of doses required
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aldara | Number of Participants With Sustained Clearance Rate of Superficial Basal Cell Carcinoma (sBCC) | 119 participants |
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)
Time frame: 12 week posttreatment visit
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aldara | Number of Participants Cleared of Superficial Basal Cell Carcinoma at 12 Weeks | 159 participants |