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Study Title and Description

Imiquimod 5% cream for the treatment of superficial and nodular basal cell carcinoma: randomized studies comparing low-frequency dosing with and without occlusion.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Imiquimod 5% cream for the treatment of superficial and nodular basal cell carcinoma: randomized studies comparing low-frequency dosing with and without occlusion.
Author Sterry W., Ruzicka T., Herrera E., Takwale A., Bichel J., Andres K., Ding L., Thissen MR.
Country Department of Dermatology, University Hospital Charité, Humboldt University, Schumannstrasse 20-21, D-10117 Berlin, Germany.
Year 2002
Numbers Pubmed ID: 12452875 - superficial

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 days/week) with occlusion
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2 Imiquimod (3 days/week) with occlusion
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3 Imiquimod (2 days/week) without occlusion
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4 Imiquimod (3 days/week) without occlusion
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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 Europe
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Funding Industry funded
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Inclusion criteria at least 18 years old and had a primary tumour that was histologically confirmed to be superficial or nodular BCC between 0.5 cm2 and 2.0 cm2 in area for the superficial BCC study and 0.25 cm2 and 1.5 cm2 in area for the nodular BCC study
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Exclusion criteria previous therapy to the target tumour or if they had any dermatological conditions that would interfere with local assessments.
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N Enrolled/Randomized/Analyzed
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... prestudy confirmatory punch, deep shave, or wedge biopsy that removed no more than approximately 25% of the tumour
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Preoperative assessment of clinical size of the tumor ... visual ... measuring and multiplying the two largest perpendicular dimensions of the tumour. The tumour site and appropriate anatomic landmarks were mapped using a clear plastic sheet as a template to guide the excision at the end of the study
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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 days/week) with occlusion Imiquimod (3 days/week) with occlusion Imiquimod (2 days/week) without occlusion Imiquimod (3 days/week) without occlusion Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 63 58 69 61
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14.2 15.8 8.5 13.9
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1.5 cm2 1.2 cm2 1.0 cm2 1.0 cm2
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Gender/Racial descent 7 8 8 11
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33 35 33 44
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Lesion location 0 0 2 8
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0 0 8 32
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forehead 7 forehead 16
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6 31 7 64
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29 16 30 1
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15 69 15 4
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71 upper extremity (not hand) 5 (22%) lower extremity (not foot) 2 (9%) 62 mons pubis
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upper extremity (not hand) 4 (19%) lower extremity (not foot) 2 (10%) upper extremity (not hand) 5 (20%) lower extremity (not foot) 2 (8%) upper extremity (not hand) 7 (28%) lower extremity (not foot) 1 (4%)
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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 21 23 24 25
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21 23 24 25
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21 23 24 25
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21 23 24 25
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2 1 1 1
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2 1 1 1
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AE/personal reasons personal reasons 4, adverse events 2, local skin reaction 2 (5 had post-tx excision) lost to followup personal reasons
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19 22 23 24
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19 22 23 24
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Lesion extent number of people 21 23 24 25
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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 days/week) with occlusion Imiquimod (3 days/week) with occlusion Imiquimod (2 days/week) without occlusion Imiquimod (3 days/week) without occlusion


12 weeks

N Analyzed 21 23 24 25
Counts 12 3 12 6
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure Imiquimod (2 days/week) with occlusion Imiquimod (3 days/week) with occlusion Imiquimod (2 days/week) without occlusion Imiquimod (3 days/week) without occlusion


6 weeks

N Analyzed 21 23 24 25
Counts 0 1 1 0
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure Imiquimod (2 days/week) with occlusion Imiquimod (3 days/week) with occlusion Imiquimod (2 days/week) without occlusion Imiquimod (3 days/week) without occlusion


6 weeks

N Analyzed 21 23 24 25
Counts 1 0 1 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
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RCT:....Adequate allocation concealment reported Yes
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RCT:....Adequate blinding of PATIENTS reported No
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RCT:....Adequate blinding of PROVIDERS reported No
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Unsure
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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). Not immediately evident
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RCT.....Is the treatment effect by Intention to treat? No
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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 Few AEs reported by arm; in general unclear AE reporting
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Overall, by outcome (judgement - put directly into notes field) Overall low RoB for efficacy and moderate to high RoB for AEs
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes
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Quality Rating
No quality rating data was found.