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Study Title and Description

Therapeutic response of basal cell carcinoma to the immune response modifier imiquimod 5% cream.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Therapeutic response of basal cell carcinoma to the immune response modifier imiquimod 5% cream.
Author Beutner KR., Geisse JK., Helman D., Fox TL., Ginkel A., Owens ML.
Country Department of Dermatology, University of California, San Francisco, the Department of Medicine, Sutter Solano Medical Center, Vallejo, Solano Dermatology Associates, Vallejo, CA, USA.
Year 1999
Numbers Pubmed ID: 10570388

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 imiquimod 2x/day
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2 imiquimod 1x/day
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3 imiquimod 3x/week
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4 imiquimod 2x/week
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5 imiquimod 1x/week
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6 vehicle (3 2x/day, 2 1x/day, 2 3x/week, 2 2x/week, 2 1x/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. Unclear
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Country/Region USA
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Funding Industry funded
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Inclusion criteria biopsy-confirmed BCC with clearly visible margins that was nodular with an area of 0.5 to 1.5 cm^2, or superficial with an area of 0.5 to 2 cm^2, and that was suitable for treatment by surgical excision.
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Exclusion criteria central facial/periorificial sites
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N Enrolled/Randomized/Analyzed 35
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35
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35
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent) nd
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Secondary size assessment
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Baseline Characteristics
Question imiquimod 2x/day imiquimod 1x/day imiquimod 3x/week imiquimod 2x/week imiquimod 1x/week vehicle (3 2x/day, 2 1x/day, 2 3x/week, 2 2x/week, 2 1x/week) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 37, 81
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Gender/Racial descent 7 4 4 5 4 11
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100 100 100 100 100 100
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Lesion location 4 2 1 1 2 1
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57 50 25 20 50 9
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upper exremity upper extremity upper extremity lower extremity lower extremity 5
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1, 2 1, 1 1, 1, 1 2, 1, 1 1, 1 46
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14, 29 25, 25 25, 25, 25 40, 20, 20 25, 25 upper extremity
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anterior upper trunk, neck anterior upper trunk, posterior upper trunk anterior upper trunk, posterior upper trunk, neck anterior upper trunk, posterior upper trunk, neck anterior upper trunk, posterior upper trunk 1, 1, 3
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9, 9, 27
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anterior upper trunk, neck, posterior lower trunk
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 7 4 4 5 4 11
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100 100 100 100 100 100
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 7 4 4 5 4 11
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7 4 4 5 4 11
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7 4 4 5 4 11
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7 4 4 5 4 11
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0 0 0 0 0 0
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0 0 0 0 0 0
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7 4 4 5 4 11
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7 4 4 5 4 11
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Lesion extent number of people 6 3 4 3 2 10
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1 1 2 2 1
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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 imiquimod 2x/day imiquimod 1x/day imiquimod 3x/week imiquimod 2x/week imiquimod 1x/week vehicle (3 2x/day, 2 1x/day, 2 3x/week, 2 2x/week, 2 1x/week)


end of treatment weeks

N Analyzed 7 4 4 5 4 11
Counts 7 4 4 3 2 1
Percentage 100 100 100 60 50 9
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure imiquimod 2x/day imiquimod 1x/day imiquimod 3x/week imiquimod 2x/week imiquimod 1x/week vehicle (3 2x/day, 2 1x/day, 2 3x/week, 2 2x/week, 2 1x/week)


end of treatment weeks

N Analyzed 7 4 4 5 4 11
Counts 7 4 4 5 4 11
Percentage 100 100 100 100 100 100
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure imiquimod 2x/day imiquimod 1x/day imiquimod 3x/week imiquimod 2x/week imiquimod 1x/week vehicle (3 2x/day, 2 1x/day, 2 3x/week, 2 2x/week, 2 1x/week)


end of treatment weeks

N Analyzed 7 4 4 5 4 11
Counts 3 1 0 2 1 1
Percentage 43 25 0 40 25 9


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data
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RCT:....Adequate allocation concealment reported No Data
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RCT:....Adequate blinding of PATIENTS reported Unsure
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RCT:....Adequate blinding of PROVIDERS reported Yes
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No Data
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No
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ALL.....Selective Reporting (judgement - put directly into notes field). No
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RCT.....Is the treatment effect by Intention to treat? Yes no dropouts or crossover
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ALL....Group similarity at baseline. No Group sizes are very small
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) No
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
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Overall, by outcome (judgement - put directly into notes field) Moderate to high RoB due to small sample size and baseline differences
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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.