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Study Title and Description

Comparison of imiquimod 5% cream versus radiotherapy as treatment for eyelid basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Comparison of imiquimod 5% cream versus radiotherapy as treatment for eyelid basal cell carcinoma.
Author Garcia-Martin E., Gil-Arribas LM., Idoipe M., Alfaro J., Pueyo V., Pablo LE., Fernandez FJ.
Country Ophthalmology Department, Miguel Servet University Hospital, Zaragoza, Spain. egmvivax@yahoo.com
Year 2011
Numbers Pubmed ID: 21242584

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 radiotherapy
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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 Spain
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Funding NR
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Inclusion criteria nodular BCC on the eyelid
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Exclusion criteria previous therapies for the BCC, the presence of other dermatological diseases such as Gorlin syndrome, psoriasis or constitutional dermatitis, and immunocompromised status, aggressive varieties of BCC such as morpheaform (sclerosing or infiltrative) BCC
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N Enrolled/Randomized/Analyzed 27
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27
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27
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... punch of diameter 4 mm
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Preoperative assessment of clinical size of the tumor ... visual ...
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Percent non-primary (recurrent) nd
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Baseline Characteristics
Question imiquimod 5% radiotherapy Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 73.13 74.18
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53-84 65-83
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7.6 (mm) 7.41
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2-12 4-12
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Gender/Racial descent 5 5
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33.3 41.7
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Lesion location 15 12
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100 100
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Skin type (Fitzpatrick score) nd nd
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Number of lesions per patient nd nd
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Previous treatments 0 0
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0 0
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Immunocompromized status nd nd
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Number of patients/lesions 15 12
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nd nd
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15 12
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nd nd
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0 0
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nd nd
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15 12
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nd nd
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Lesion extent number of people 15 15 27
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Recurrence or incomplete excision      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


3 months

N Analyzed 15 12
Counts 0 0


6 months

N Analyzed 15 12
Counts 0 0


12 months

N Analyzed 15 12
Counts 0 0


24 months

N Analyzed 15 12
Counts 0 0
Outcome: Adverse events: discomfort      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


4 weeks

N Analyzed 15 12
Counts 9 6
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


4 weeks

N Analyzed 15 12
Counts 2 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


4 weeks

N Analyzed 15 12
Counts 0 1
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


6 weeks

N Analyzed 15 12
Counts 15 0
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


15 weeks

N Analyzed 15 12
Counts 0 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


15 weeks

N Analyzed 15 12
Counts 15 12
Outcome: Adverse events: other      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


4 weeks

N Analyzed 15 12
Counts 0 2
Outcome: Adverse events: other      Population: All Participants
Time Point Measure imiquimod 5% radiotherapy


4 weeks

N Analyzed 15 12
Counts 0 12


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unclear RoB
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RCT:....Adequate allocation concealment reported Unclear RoB
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RCT:....Adequate blinding of PATIENTS reported High RoB
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RCT:....Adequate blinding of PROVIDERS reported Moderate RoB
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Unclear RoB
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Low RoB
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ALL.....Selective Reporting (judgement - put directly into notes field). opthomologist rated cosmetic outcome prespecified in the methods but not reported in the results
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RCT.....Is the treatment effect by Intention to treat? Low RoB
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ALL....Group similarity at baseline. Low RoB
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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 Low RoB
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Overall, by outcome (judgement - put directly into notes field) Overall low to moderate RoB due to lack of blinding
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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
Guideline Used Overall Rating