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Study Title and Description

Imiquimod 5% cream monotherapy for cutaneous squamous cell carcinoma in situ (Bowen's disease): a randomized, double-blind, placebo-controlled trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Imiquimod 5% cream monotherapy for cutaneous squamous cell carcinoma in situ (Bowen's disease): a randomized, double-blind, placebo-controlled trial.
Author Patel GK., Goodwin R., Chawla M., Laidler P., Price PE., Finlay AY., Motley RJ.
Country Welsh Institute of Dermatology, University Hospital of Wales, Cardiff, United Kingdom. patelgk@cf.ac.uk
Year 2006
Numbers Pubmed ID: 16713457

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 Kingdom
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Funding Industry funded
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Inclusion criteria biopsy-proven cutaneous SCC in situ; full-thickness epidermal dysplasia; no active treatment 1 month prior; post-biopsy legion >=1 <=20 cm^2; at least 1 cm away from eye; had to be able to attend clinical trials room.
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Exclusion criteria
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N Enrolled/Randomized/Analyzed 31
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31
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28
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... biopsy specimen, which by conventional histologic examination showed full-thickness epidermal dysplasia
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Preoperative assessment of clinical size of the tumor ... not reported ...
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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 74 74
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8 8
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54, 83 60, 86
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429 248
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489 166
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23, 1776 84, 555
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Gender/Racial descent 6 14
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40 87.5
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Lesion location No data entered.
Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient No data entered.
Previous treatments 6 5
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40 31.25
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not specified not specified
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Immunocompromized status No data entered.
Number of patients/lesions 15 16 31
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15 16 31
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15 16 31
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15 16 31
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3 16 3
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3 16 3
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12 28
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12 28
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Lesion extent number of people No data entered.
Lesion extent number of people 15 16 31
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Results & Comparisons


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


28 weeks

N Analyzed 12 16
Counts 3 16
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure imiquimod 5% vehicle


28 weeks

N Analyzed 12 16
Counts 3 16
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure imiquimod 5% vehicle


28 weeks

N Analyzed 15 16
Counts 2 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 Yes
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RCT:....Adequate blinding of PROVIDERS reported Yes
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes 3/15
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ALL.....Selective Reporting (judgement - put directly into notes field).
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RCT.....Is the treatment effect by Intention to treat? No
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ALL....Group similarity at baseline. No legion size different between groups
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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-defined, not reported by arm
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Overall, by outcome (judgement - put directly into notes field) Overall high RoB, blinding is good but groups are not similar, there is differential missingness, and outcomes are not reported by arm
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes 20% in one arm, no dropout in other arm
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Quality Rating
No quality rating data was found.