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Study Title and Description

Evaluation of superficial basal cell carcinomas after treatment with imiquimod 5% cream or vehicle for apoptosis and lymphocyte phenotyping.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Evaluation of superficial basal cell carcinomas after treatment with imiquimod 5% cream or vehicle for apoptosis and lymphocyte phenotyping.
Author Sullivan TP., Dearaujo T., Vincek V., Berman B.
Country Department of Dermatology and Cutaneous Surgery, University of Miami School of Medicine, PO Box 016250 (R-250), Miami, FL 33101, USA. tsullivan@med.miami.edu
Year 2003
Numbers Pubmed ID: 14725659

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 imiquimod 5%
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2 vehicle
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Design Details
Question... Follow Up Answer Follow-up Answer
Study design Prospective nRCS
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Multicenter etc. Single center
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Country/Region US
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Funding NR
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Inclusion criteria biopsy confirmed superficial BCC measuring from 0.8 to 2.0 cm in diameter on the neck, trunk, or limbs.
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Exclusion criteria recurrent or previously treated tumors or tumors located on the head
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N Enrolled/Randomized/Analyzed 12
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12
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12
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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) 0
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Secondary size assessment
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Baseline Characteristics
Question imiquimod 5% vehicle Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 63.3 58.8
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9.5 7.5
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mm mm
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52.25 52.2
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mm^2 mm^2
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Gender/Racial descent No data entered.
Lesion location No data entered.
Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 6 6 12
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100 100 100
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 6 6 12
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6 6 12
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6 6 12
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6 6 12
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0 0 0
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0 0 0
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6 6 12
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6 6 12
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Lesion extent number of people 6 6 12
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure imiquimod 5% vehicle


4 weeks

N Analyzed 6 6
Counts 0 0
Percentage 0 0
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure imiquimod 5% vehicle


4 weeks

N Analyzed 6 6
Counts 4 6
Percentage 66.7 100
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure imiquimod 5% vehicle


4 weeks

N Analyzed 6 6
Counts 2 3


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported
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RCT:....Adequate allocation concealment reported
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RCT:....Adequate blinding of PATIENTS reported
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RCT:....Adequate blinding of PROVIDERS reported
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes dermatologist and pathologist blinded
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? No no missing
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ALL.....Selective Reporting (judgement - put directly into notes field). Yes no AEs
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RCT.....Is the treatment effect by Intention to treat?
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ALL....Group similarity at baseline. some differences, but most likely due to small sample size
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) small sample size (6 per arm)
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No Data none reported
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Overall, by outcome (judgement - put directly into notes field) moderate to high - baseline imbalanced due to small sample size, NRCS, no AEs
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No no missing
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Quality Rating
No quality rating data was found.