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Study Title and Description

A phase III, randomized, open label study to evaluate the safety and efficacy of imiquimod 5% cream applied thrice weekly for 8 and 12 weeks in the treatment of low-risk nodular basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title A phase III, randomized, open label study to evaluate the safety and efficacy of imiquimod 5% cream applied thrice weekly for 8 and 12 weeks in the treatment of low-risk nodular basal cell carcinoma.
Author Eigentler TK., Kamin A., Weide BM., Breuninger H., Caroli UM., Möhrle M., Radny P., Garbe C.
Country Skin Cancer Program, Department of Dermatology, Eberhard-Karls-University, Tuebingen, Germany.
Year 2007
Numbers Pubmed ID: 17610993

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% (8)
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2 imiquimod 5% (12)
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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 Germany
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Funding NR
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Inclusion criteria to adults with at least one clinically typical and histologically confirmed primary nBCC tumor of limited size (maximum, 1.5 cm in diameter)
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Exclusion criteria micronodular, infiltrative, superficial, or morpheic BCCs, as well as BCCs with multicentric growth pattern, or within 0.5 cm of the eyes
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N Enrolled/Randomized/Analyzed 102
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102
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90
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... visual ... the lesion was documented by photography and the silhouette was traced on a plastic film.
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question imiquimod 5% (8) imiquimod 5% (12) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 65 63
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38, 88 39, 79
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8.2 9.6
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8.0 9.0
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4, 15 5, 15
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mm nd
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nd nd
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nd
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Gender/Racial descent 12 15
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27% 33%
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Lesion location 11 9
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24.4 19.6
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1 1
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2.2 2.2
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4 5
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8.9 10.9
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2 3
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4.4 8.7
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Perioral: 2, 4.4% Periorbital: 4, 8.9% Nose: 19, 42.2% Arm/shoulder: 2, 4.4% Leg/hip: 0, 0% Perioral: 1, 2.2% Periorbital: 3, 6.5% Nose: 17, 37.0% Arm/shoulder: 2, 4.4% Leg/hip: 2, 4.3%
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Skin type (Fitzpatrick score) 0 2
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0 4.4
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22 23
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51.0 52.2
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20 19
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44.4 41.3
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2 1
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4.4 2.2
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Number of lesions per patient nd
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 53 49
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nd nd
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53 49
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nd nd
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8 4
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nd nd
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One patient had SCC and 7 refused final histological and clinical evaluation 1 had a tumor size out of the upper limit, 2 withdrew consent before start of therapy, 1 refused final histological and clinical evaluation
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45 45
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nd nd
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Lesion extent number of people 45 45
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45 45
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Lack of clinical clearance      Population: All Participants Between-Arm Comparisons
Time Point Measure imiquimod 5% (8) imiquimod 5% (12) Comparison Measure imiquimod 5% (8) vs. imiquimod 5% (12)


8 weeks

N Analyzed 45 45 0.240
Percentage 17.8 26.1
Counts 8 12
P-Value
Outcome: Lack of histological clearance      Population: All Participants Between-Arm Comparisons
Time Point Measure imiquimod 5% (8) imiquimod 5% (12) Comparison Measure imiquimod 5% (8) vs. imiquimod 5% (12)


8 weeks

N Analyzed 45 45 0.534
Percentage 35.6 37.0
Counts 16 17
P-Value
Outcome: Adverse events: Any      Population: All Participants Between-Arm Comparisons
Time Point Measure imiquimod 5% (8) imiquimod 5% (12) Comparison Measure imiquimod 5% (8) vs. imiquimod 5% (12)


8 weeks

N Analyzed 45 45 NS


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data
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RCT:....Adequate allocation concealment reported No Data
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RCT:....Adequate blinding of PATIENTS reported No
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RCT:....Adequate blinding of PROVIDERS reported No Data
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No Data
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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).
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RCT.....Is the treatment effect by Intention to treat? No
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ALL....Group similarity at baseline. Unsure
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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 Unsure partial reporting, but they say there's no difference between arms
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Overall, by outcome (judgement - put directly into notes field) impact of potential attrition bias is moderate to low
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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.