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Study Title and Description

Imiquimod 5% cream as adjunctive therapy for primary, solitary, nodular nasal basal cell carcinomas before Mohs micrographic surgery: a randomized, double blind, vehicle-controlled study.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Imiquimod 5% cream as adjunctive therapy for primary, solitary, nodular nasal basal cell carcinomas before Mohs micrographic surgery: a randomized, double blind, vehicle-controlled study.
Author Butler DF., Parekh PK., Lenis A.
Country Department of Dermatology, Scott & White Memorial Hospital and Clinic, Texas A&M University College of Medicine, Temple, Texas, USA. dfbutler@swmail.sw.org
Year 2009
Numbers Pubmed ID: 19018814

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Vehicle group+MOHs
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2 imiquimod 5% Cream group+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. Single center
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Country/Region texas, usa
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Funding Industry funded
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Inclusion criteria Immunocompetent, nonpregnant adults aged 18 and older with primary nodular nasal BCCs less than 1 cm in size
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Exclusion criteria ogist. BCCs that displayed superficial, morpheaform, or micronodular histologic subtypes were excluded.
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N Enrolled/Randomized/Analyzed 31
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31
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31 (ITT) 28 actual
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... histological confirmation of BCC before study enrollment with a 2-mm punch biopsy by a pathol- ogist.
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Preoperative assessment of clinical size of the tumor ... not reported ... presumably visual
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Percent non-primary (recurrent)
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Secondary size assessment
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Baseline Characteristics
Question Vehicle group+MOHs imiquimod 5% Cream group+MOHs Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 75.3 73.3
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11.4 10.5
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48-93 42-85
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30.1mm2 33.5 mm2
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9.5 mm2 12.8 mm2
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19.2-50.4 mm2 14.4-57.6 mm2
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Gender/Racial descent 7 10
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43.8% 66.7%
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Lesion location 16 15
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100 100
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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 16 15
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16 15
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16 15
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16 15
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0 3
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0 3
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16 2 secondary to local adverse events and 1 bc of non-study related illness
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16 12
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12
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Lesion extent number of people 16 (100%) 15 (100%)
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure Vehicle group+MOHs imiquimod 5% Cream group+MOHs


3 weeks

N Analyzed 16 13
Counts 4 10


6 weeks

N Analyzed 16 13
Counts 2 10
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Vehicle group+MOHs imiquimod 5% Cream group+MOHs


3 weeks

N Analyzed 16 13
Counts 0 9


6 weeks

N Analyzed 16 13
Counts 1 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Vehicle group+MOHs imiquimod 5% Cream group+MOHs


3 weeks

N Analyzed 16 13
Counts 0 1


6 weeks

N Analyzed 16 13
Counts 0 0
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure Vehicle group+MOHs imiquimod 5% Cream group+MOHs


10 weeks

N Analyzed 16 12
Counts 14 7


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? No
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ALL.....Selective Reporting (judgement - put directly into notes field). No
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RCT.....Is the treatment effect by Intention to treat? No 3 patients who failed to complete the study were included as treatment failures. this is not ITT.
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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) No
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined Yes
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Overall, by outcome (judgement - put directly into notes field) low for all outcomes
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? No 3 patients in imiquimod group and 0 patients in vehicle groupp
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Quality Rating
No quality rating data was found.