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Study Title and Description

Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma: comparison of dosing regimens - 12 Week Study



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Efficacy of topical 5% imiquimod cream for the treatment of nodular basal cell carcinoma: comparison of dosing regimens - 12 Week Study
Author Shumack S., Robinson J., Kossard S., Golitz L., Greenway H., Schroeter A., Andres K., Amies M., Owens M.
Country St George Dermatology and Skin Cancer Center, Level 3, 22 Belgrave St, Kogarah, Australia 2217. sshumack@bigpond.com
Year 2002
Numbers Pubmed ID: 12224977-12 week

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 vehicle cream
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2 imiquimod (IMQ) 5% cream - Twice daily for 7 days per week
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3 imiquimod (IMQ) 5% cream - Once daily for 7 days per week
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4 imiquimod (IMQ) 5% cream - Once daily for 5 days per week
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5 imiquimod (IMQ) 5% cream - Once daily for 3 days per week
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design RCT
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Multicenter etc. Multicenter
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Country/Region Australia and New Zealand; And United States
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Funding NR
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Inclusion criteria at least 18 years old and had a primary target tumor that was histologically confirmed as nodular BCC. Target tumors suitable for treatment in these 2 studies measured 0.5 to 1.5 cm2 in area and were greater than 1 cm from the eyes, nose, mouth, ear, and hairline.
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Exclusion criteria Basal cell carcinomas with morpheic infiltrating and micronodular patterns were excluded from these studies.
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N Enrolled/Randomized/Analyzed 92
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92
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77
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... each patient underwent a confirmatory punch or shave biopsy of the target tumor. Investigators were encouraged to use a 2- to 3-mm punch and to remove no more than approximately 25% of the target tumor area. Biopsies extended through the entire depth of the tumor and into the reticular dermis, which was confirmed during the histologic assessment. Biopsy specimens were sent to a central dermatopathology laboratory where they were paraffin processed, stained with hematoxylin and eosin, and microscopically examined for BCC. The presence of a nodular BCC in each biopsy specimen was verified by an independent dermatopathologist.
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Preoperative assessment of clinical size of the tumor ... visual ... Target tumors were measured (size ex- pressed as area in square centimeters) and photographed prior to the prestudy biopsy and rephotographed prior to treatment initiation and at each interval visit.
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Percent non-primary (recurrent) 0%
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Secondary size assessment NR
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Baseline Characteristics
Question vehicle cream imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 5 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 62 53 63 63 58
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11.5 25.9 14.1 13.1 13.0
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0.8 0.8 0.7 0.7 0.7
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median lesion area (cm^2) median lesion area (cm^2) median lesion area (cm^2) median lesion area (cm^2) median lesion area (cm^2)
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Gender/Racial descent 10 3 2 8 6 29
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42 75 10 35 30 31.5
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24 4 21 23 20 92
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100 100 100 100 100 100
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Lesion location 4 Upper extremity (not hand): 0 Lower extremity (not foot): 0 Upper extremity (not hand): 4 (19%) Lower extremity (not foot): 2 (10%) Upper extremity (not hand): 4 (17%) Lower extremity (not foot): 2 (9%) Upper extremity (not hand): 4 (20%) Lower extremity (not foot): 1 (5%)
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17 1 6 11 8
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13 25 29 48 40
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54.2 3 9 6 7
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Upper extremity (not hand): 6 (25.0%) Lower extremity (not foot): 1 (4.0%) 75 33 26 35
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 24 4 21 23 20 92
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NR, but assumed 100 100 100 100 100
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100 NR, but assumed NR, but assumed NR, but assumed NR, but assumed NR, but assumed
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 24 4 21 23 20 92
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24 4 21 23 20 4
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15 were discontinued from the study, only 4 of whom did not undergo post-treatment excision
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88
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92
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92
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92
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4
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88
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Lesion extent number of people 24 4 21 23 20 92
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24 4 21 23 20 92
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure vehicle cream imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 5 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week


12 weeks

N Analyzed 24 4 21 23 20
Counts 21 1 5 7 8
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure vehicle cream imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 5 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week


12 weeks

N Analyzed 24 4 21 23 20
Counts 0 2 4 2 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure vehicle cream imiquimod (IMQ) 5% cream - Twice daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 7 days per week imiquimod (IMQ) 5% cream - Once daily for 5 days per week imiquimod (IMQ) 5% cream - Once daily for 3 days per week


12 weeks

N Analyzed 24 4 21 23 20
Counts 0 2 1 0 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No 92 patients randomized to Imiquimod and placebo according to the dosing scheme: - once daily for 3 days per week (20 Active, 8 Vehicle) -once daily for 5 days per week (23 A, 6 V) - once daily for 7 days per week (21 A, 10 V)
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RCT:....Adequate allocation concealment reported No Data method of allocation concealment was not reported
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RCT:....Adequate blinding of PATIENTS reported Yes
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RCT:....Adequate blinding of PROVIDERS reported No Data "double blind"
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No Data "double blind"
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No Clearance outcome was partially reported. Reported for combined vehicle separate from dosing regimen groups, where only results of imiquimod patients were reported.
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ALL.....Selective Reporting (judgement - put directly into notes field). Yes AE were defined but # of counts within each arm was not completely reported.
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RCT.....Is the treatment effect by Intention to treat? Yes 15 were discontinued from the study. Post treatment excision results were obtained for 11 of these. Intention to Treat was reported.
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ALL....Group similarity at baseline. No Twice daily for 7 days per week group (4 active, 0 control) Mean age is different from range of age in other groups and combined vehicle
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Yes
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No AE were defined but # of counts within each arm was not completely reported.
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Overall, by outcome (judgement - put directly into notes field) Low RoB for clearance outcomes, unclear results for AEs
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No
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Quality Rating
No quality rating data was found.