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Study Title and Description

Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: a double-blind, randomized, 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 for the treatment of superficial basal cell carcinoma: a double-blind, randomized, vehicle-controlled study.
Author Geisse JK., Rich P., Pandya A., Gross K., Andres K., Ginkel A., Owens M.
Country Solano Dermatology Associates, Vallejo, California 94589, USA.
Year 2002
Numbers Pubmed ID: 12196749

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Imiquimod 3x/wk
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2 Imiquimod 5x/wk
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3 Imiquimod 1x/day
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4 Imiquimod 2x/day
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5 vehicle (control)
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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 U.S.
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Funding Industry funded
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Inclusion criteria >=18 years of age with a histologically confirmed diagnosis of superficial BCC between 0.5 and 2.0 cm2
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Exclusion criteria tumors within 1 cm of the hairline, eyes, nose, mouth, or ears; the anogenital area; and hands and feet, previously treated, recurrent, or within 5 cm of another BCC tumor
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N Enrolled/Randomized/Analyzed 128
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128
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125
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Notes/Comments Funder: 3M
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... A biopsy specimen of no more than 25% of the tumor area was taken for histologic confirmation of sBCC.
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Preoperative assessment of clinical size of the tumor ... visual ...
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Percent non-primary (recurrent) 0
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Secondary size assessment photographed at each followup visit
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Baseline Characteristics
Question Imiquimod 3x/wk Imiquimod 5x/wk Imiquimod 1x/day Imiquimod 2x/day vehicle (control) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 62 55 56 69 58
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36, 85 38, 84 35, 85 51, 85 38, 85
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1.0 cm2 0.6 cm2 0.7 cm2 1.0 cm2 0.8 cm2
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Gender/Racial descent No data entered.
Lesion location 1 1 2 1 3
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neck/face/forehead neck/face/forehead neck/face/forehead neck/face/forehead neck/face/forehead
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4 9 6 7 11
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upper extremity (not hand) upper extremity (not hand) upper extremity (not hand) upper extremity (not hand) upper extremity (not hand)
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19 16 18 4 15
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trunk trunk trunk trunk trunk
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lower extremity/thigh (not foot) 2 lower extremity/thigh (not foot) 3 lower extremity/thigh (not foot) 2 lower extremity/thigh (not foot) 1 lower extremity/thigh (not foot) 3
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Skin type (Fitzpatrick score) 16
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13
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59
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46
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44
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34
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9
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7
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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 29 26 31 10 32 128
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29 1 1 10 32 128
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29 25 30 10 1 24 withdrew from treatment, but were followed to the end of the study (ITT analysis); 3 were lost to followup
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29 26 31 10 31 Overall, 13 (10.2%) patients discontinued treatment because of local skin reactions, including 3 from the twice-daily group, 7 from the once-daily group, and 3 from the 5-times-a-week group. Four (3.1%) patients discontinued because of application site adverse events, including 1 from the twice-daily group, 2 from the once-daily group and 1 from the 5-times-a-week group. Some of these discontinuations were not the choice of the patient, but were imposed by the investigator because the maximum 14-day rest from dosing allowed by the protocol had been exceeded. Also, 2 (1.6%) discontinued because of noncompliance, 2 (1.6%) for personal reasons, 2 (1.6%) were lost to follow-up, and 1 (0.8%) was discontinued for a laboratory abnormality identified at initiation.
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29 26 31 10 32 125
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0 26 31 0 32 128
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0 1 1 0 1 128
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29 25 30 10 31 24/3
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125
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Lesion extent number of people 116
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12
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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 3x/wk Imiquimod 5x/wk Imiquimod 1x/day Imiquimod 2x/day vehicle (control)


18 weeks

N Analyzed 29 25 30 10 31
Counts 14 5 4 0 26
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod 3x/wk Imiquimod 5x/wk Imiquimod 1x/day Imiquimod 2x/day vehicle (control)


18 weeks

N Analyzed 29 26 31 10 32
Counts 16 20 25 8 8
Percentage 55 77 81 80 25
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure Imiquimod 3x/wk Imiquimod 5x/wk Imiquimod 1x/day Imiquimod 2x/day vehicle (control)


18 weeks

N Analyzed 29 26 31 10 32
Counts 11 16 19 3 4
Percentage 38 62 61 30 13
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Imiquimod 3x/wk Imiquimod 5x/wk Imiquimod 1x/day Imiquimod 2x/day vehicle (control)


18 weeks

N Analyzed 29 26 31 10 32
Counts 3 2 5 3 0
Percentage 10 8 16 30 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod 3x/wk Imiquimod 5x/wk Imiquimod 1x/day Imiquimod 2x/day vehicle (control)


18 weeks

N Analyzed 29 26 31 10 32
Counts 2 2 5 2 2
Percentage 7 8 16 20 6


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). I don't see any sign of overt selective reporting
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. No ages and locations of tumors differ
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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 AE reporting was there, but inconsistent (sometimes by arm, sometimes with numbers, etc)
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Overall, by outcome (judgement - put directly into notes field) Overall low RoB, moderate RoB for AEs. Other than the AE reporting, seems to be pretty good
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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.