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Study Title and Description

Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: results from a randomized vehicle-controlled phase III study in Europe.



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 basal cell carcinoma: results from a randomized vehicle-controlled phase III study in Europe.
Author Schulze HJ., Cribier B., Requena L., Reifenberger J., Ferrándiz C., Garcia Diez A., Tebbs V., McRae S.
Country Clinique Dermatologique, Strasbourg, France. schulze@fachklinik-hornheide.de
Year 2005
Numbers Pubmed ID: 15888150

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. Multicenter
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Country/Region Europe
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Funding Industry funded
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Inclusion criteria men and non-pregnant women >= 18 years old; histologically confirmed primary sBCC on limbs, trunk, neck, or head; minimum area of 0.5 cm^2 and maximum diameter of 2.0 cm prior to biopsy.
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Exclusion criteria clinically significant, unstable medical conditions; metastatic tumor or tumor with high probability of metastatic spread; tumor on anogenital area or within 1 cm of the hairline, nose, mouth, ears, and eyes; histological evidence morphoeic, severe squamous metaplasia, or any infliltrative or desmoplastic features; dermatological disease within 5 cm of target site margins that would be exacerbated by treatment and would affect assessment.
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N Enrolled/Randomized/Analyzed 166
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166
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166
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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 ... multiplying the two largest diameters perpendicular to each other
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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% vehicle Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 64.3 64.5 64.4
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13.06 11.43 12.25
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67 68 67
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25, 83 31, 86 25, 86
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Gender/Racial descent 84 82 65
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100 100 39
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166
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100
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Lesion location 1/1/0 5/1/4 6/2/4
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1/1/0 6/1/5 4/1/2
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total/cheek/forehead total/cheek/forehead total/cheek/forehead
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0 1 1
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0 1 1
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17/7/10 24/8/16 41/15/26
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20/8/12 29/10/20 25/9/16
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total/lower/upper (including hand) total/lower/upper (including hand) total/lower/upper (including hand)
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59/4/17/13/25/7 50/0/16/13/21/2 109/4/33/26/46/9
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70/5/20/15/30/8 61/0/20/16/26/2 66/2/20/16/28/5
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total trunk/anterior lower/anterior upper/posterior lower/posterior upper/neck total trunk/anterior lower/anterior upper/posterior lower/posterior upper/neck total trunk/anterior lower/anterior upper/posterior lower/posterior upper/neck
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Skin type (Fitzpatrick score) 4 1 5
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5 1 3
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40 38 78
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48 46 47
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35 34 69
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42 41 42
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4 8 12
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5 10 7
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1 1 2
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1 1 1
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Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 84 82 166
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84 82 166
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N/A N/A N/A
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84 82 166
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84 82 166
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N/A N/A N/A
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84 82 166
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84 82 166
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N/A N/A N/A
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Lesion extent number of people 84 82
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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% vehicle Comparison Measure imiquimod 5% vs. vehicle


12 weeks

N Analyzed 84 82 <0.001
Percentage 23 94
Counts 19 77
P-Value
Outcome: Lack of histological clearance      Population: All Participants Between-Arm Comparisons
Time Point Measure imiquimod 5% vehicle Comparison Measure imiquimod 5% vs. vehicle


12 weeks

N Analyzed 84 82 <0.001
Percentage 20 94
Counts 17 77
P-Value
Outcome: Adverse events: skin irritation      Population: All Participants Between-Arm Comparisons
Time Point Measure imiquimod 5% vehicle Comparison Measure imiquimod 5% vs. vehicle


12 weeks

N Analyzed 84 82 <0.001
Counts 27 1
Percentage 32 1
P-Value
Outcome: Adverse events: skin irritation      Population: All Participants Between-Arm Comparisons
Time Point Measure imiquimod 5% vehicle Comparison Measure imiquimod 5% vs. vehicle


12 weeks

N Analyzed 84 82 <0.001
Counts 19 0
Percentage 23 0
P-Value
Outcome: Adverse events: skin irritation      Population: All Participants Between-Arm Comparisons
Time Point Measure imiquimod 5% vehicle Comparison Measure imiquimod 5% vs. vehicle


12 weeks

N Analyzed 84 82 <0.001
Counts 8 0
Percentage 10 0
P-Value
Outcome: Adverse events: skin irritation      Population: All Participants Between-Arm Comparisons
Time Point Measure imiquimod 5% vehicle Comparison Measure imiquimod 5% vs. vehicle


12 weeks

N Analyzed 84 82 <0.001
Counts 5 0
Percentage 6 0
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure imiquimod 5% vehicle


12 weeks

N Analyzed 84 82
Counts 2 1


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes randomized to imiquimod or vehicle in a 1 : 1 ratio according to a computer-generated randomization schedule
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RCT:....Adequate allocation concealment reported Yes Study personnel remained blinded to the randomization until the database was complete and locked.
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RCT:....Adequate blinding of PATIENTS reported Yes Subjects, study personnel and the sponsor’s clinical research team were blinded to study cream identity and treatment assignment
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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? Yes
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ALL.....Selective Reporting (judgement - put directly into notes field). Yes
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RCT.....Is the treatment effect by Intention to treat? Yes
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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
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Overall, by outcome (judgement - put directly into notes field) No Overall low RoB.
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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.