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Study Title and Description

5% imiquimod cream and reflectance-mode confocal microscopy as adjunct modalities to Mohs micrographic surgery for treatment of basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title 5% imiquimod cream and reflectance-mode confocal microscopy as adjunct modalities to Mohs micrographic surgery for treatment of basal cell carcinoma.
Author Torres A., Niemeyer A., Berkes B., Marra D., Schanbacher C., González S., Owens M., Morgan B.
Country Loma Linda University Medical Center, Dermatology Office, Faculty Medical Offices, Loma Linda, California 92354, USA. ABELT@aol.com
Year 2004
Numbers Pubmed ID: 15606733

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 imiquimod, 2 weeks pt applied imiquimod 5x/week x 2 weeks prior to MOHs.
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2 imiquimod, 4 weeks pt applied imiquimod 5 x/week x 4 weeks prior to MOHs
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3 imiquimod, 6 weeks pt applied imiquimod 5x/week x 6 weeks prior to MOHs
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4 vehicle controlled-pooled applied study cream 5x/week for 2, 4, or 6 weeks prior to MOHs.
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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 loma linda, CA; boston, MA
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Funding Industry funded
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Inclusion criteria biopsy proven BCC; less than or equal to 25% of the lesion removed at time of biopsy. 18 years old with a histologically confirmed, primary, superficial, nodular, or mixed superficial and nodular basal cell carcinoma tumor. The tumor selected for treatment was required to be consistent with basal cell carcinoma with no histologic evidence of aggressive growth patterns, including severe squamous metapl- asia, morpheaform or infiltrative/desmoplastic fea- tures, or basosquamous features, and suitable for treatment with Mohs micrographic surgery excision. Micronodular tumors were not specifically excluded. Target tumors were to have a minimum area of 0.5 cm2 and a maximum diameter of 2.0 cm and could be located on an acceptable area of the body as deter- mined by the investigator.
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Exclusion criteria excluded if they had previous therapy to the target tumor or if they had dermatologic conditions that could interfere with skin assessments.
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N Enrolled/Randomized/Analyzed 72
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72
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69
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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 ... visual ... use of tattoo in center of lesion
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confocal ...
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Percent non-primary (recurrent) 0%
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Secondary size assessment
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Baseline Characteristics
Question imiquimod, 2 weeks imiquimod, 4 weeks imiquimod, 6 weeks vehicle controlled-pooled Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 60.9 61.6 70.6 63.6
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9.4 14.4 13.3 13.5
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0.9 0.8 1.2 1.2
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0.2,2.0 0.5,1.3 0.5,2.7 0.5,2.9
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area given for median target tumor size after biopsy area given for median target tumor size after biopsy area given for median target tumor size after biopsy area given for median target tumor size after biopsy
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12 12 12 36
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1 pt excluded bc the presence of tumor was indeterminate owing to local inflammation 2 pt excluded from final analysis bc the presence of tumor was indeterminable owing to local inflammation
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Gender/Racial descent 4 5 4 7
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33.3 41.7 33.3 19.4
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Lesion location No data entered.
Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 72
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69 evaluated as 3 excluded from study *see above
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 12 12 12 36
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12 12 12 36
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0 0 1 2
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12 12 inevaluable owing to local inflammation/oresence of tumor was indeterminate inevaluable owing to local inflammation/oresence of tumor was indeterminate
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11 34
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Lesion extent number of people 12 4 2 "nodular" and "nodular or mixed basal cell" added together
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5 8 10 12
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7 "nodular" and "nodular or mixed basal cell" added together "nodular" and "nodular or mixed basal cell" added together 24
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"nodular" and "nodular or mixed basal cell" added together
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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, 2 weeks imiquimod, 4 weeks imiquimod, 6 weeks vehicle controlled-pooled


2 weeks post imquimod regimen completion weeks

N Analyzed 12 12 11 34
Counts 9 4 4 34
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure imiquimod, 2 weeks imiquimod, 4 weeks imiquimod, 6 weeks vehicle controlled-pooled


throughout study period N/A

N Analyzed 12 12 12 36
Counts 2 6 7 4
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure imiquimod, 2 weeks imiquimod, 4 weeks imiquimod, 6 weeks vehicle controlled-pooled


throughout study period N/A

N Analyzed 12 12 12 36
Counts 0 0 0 0
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure imiquimod, 2 weeks imiquimod, 4 weeks imiquimod, 6 weeks vehicle controlled-pooled


throughout study period N/A

N Analyzed 12 12 12 36
Counts 0 0 0 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes computer-generated schedule
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RCT:....Adequate allocation concealment reported No
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RCT:....Adequate blinding of PATIENTS reported Yes
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RCT:....Adequate blinding of PROVIDERS reported Yes
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Unsure histologist
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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 probably not
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. Yes
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field)
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No Not well reported
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Overall, by outcome (judgement - put directly into notes field) Overall low RoB
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome?
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Quality Rating
No quality rating data was found.