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Study Title and Description

Pilot study of imiquimod 5% cream as adjunctive therapy to curettage and electrodesiccation for nodular basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Pilot study of imiquimod 5% cream as adjunctive therapy to curettage and electrodesiccation for nodular basal cell carcinoma.
Author Spencer JM.
Country Department of Dermatology, Mt. Sinai School of Medicine, New York, NY, USA. jgspencer@tampabay.rr.com
Year 2006
Numbers Pubmed ID: 16393600

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
Publication or abstract? Publication
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Study design RCT
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Multicenter etc. Single center
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Country/Region United States
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Funding Industry funded
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Inclusion criteria >= 18 years of age; previously untreated histologically confirmed nBCC.
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Exclusion criteria comorbidities that would interfere with or be exacerbated by treatment.
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N Enrolled/Randomized/Analyzed 20
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20
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20
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... histologically confirmed
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Preoperative assessment of clinical size of the tumor ... visual ...
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Percent non-primary (recurrent)
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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 No data entered.
Gender/Racial descent 4 1 20
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40 10 100%
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10 10
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100% 100%
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Lesion location 6 5
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60 50
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1 2
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10 20
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3 (30%) 3 (30%)
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 10 10 20
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10 10 20
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10 10 20
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10 10 20
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10 10 20
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10 10 20
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Lesion extent number of people 10 10
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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 5% vehicle


8 weeks

N Analyzed 10 10
Counts 1 4
Percentage 10 40
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure imiquimod 5% vehicle


8 weeks

N Analyzed 10 10
Counts 3 8
Percentage 30 80




N Analyzed
Mean
SD
SE




N Analyzed
Mean
SD
SE
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure imiquimod 5% vehicle


4 weeks

N Analyzed 10 10
Counts 4 10
Percentage 40 100


8 weeks

N Analyzed 10 10
Counts 10 10
Percentage 100 100
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure imiquimod 5% vehicle


8 weeks

N Analyzed 10 10
Counts 0 0
Percentage 0 0
Outcome: Cosmetic outcome (continuous)      Population: All Participants
Time Point Measure imiquimod 5% vehicle


8 weeks

N Analyzed 10 10
Mean 4.5 4.2


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data randomization not reported
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RCT:....Adequate allocation concealment reported No Data
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RCT:....Adequate blinding of PATIENTS reported No Data
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RCT:....Adequate blinding of PROVIDERS reported No Data
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No blinding not reported
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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 not all time points reported.
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RCT.....Is the treatment effect by Intention to treat? Yes no dropouts
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ALL....Group similarity at baseline. Unsure very low n
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) No blinding and randomization procedure not defined
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No
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Overall, by outcome (judgement - put directly into notes field) Overall fairly high risk of bias
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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.