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Study Title and Description

Imiquimod 5% cream for the treatment of superficial basal cell carcinoma: results from two phase III, randomized, vehicle-controlled studies.



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 two phase III, randomized, vehicle-controlled studies.
Author Geisse J., Caro I., Lindholm J., Golitz L., Stampone P., Owens M.
Country Solano Dermatology Associates, Vallejo, CA 94589, USA. jgeisse@solderm.com
Year 2004
Numbers Pubmed ID: 15097956

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Imiquimod 5x/wk
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2 Vehicle 5x/wk or 7x/wk
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3 Imiquimod 7x/wk
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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 old with a primary, histologically-confirmed superficial BCC >= 0.5 cm2, diameter <= 2.0 cm on the limbs, trunk (excluding the anogenital area), neck, or head (excluding the H-zone)
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Exclusion criteria any dermatological disease in the target sBCC site or surrounding area that could be exacerbated by imiquimod or cause difficulty with examination (such as subjects with nevoid basal cell carcinoma syndrome)
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N Enrolled/Randomized/Analyzed 724
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724
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694
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Notes/Comments Funder: 3M
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... confirmatory punch or shave biopsy < 25% of the tumor area
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Preoperative assessment of clinical size of the tumor ... visual ... clinically evident tumor margins and local landmarks
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Percent non-primary (recurrent) 0
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Secondary size assessment Lesion site measurements were taken at prestudy, initiation, and the posttreatment excision visit. Photographs of the lesion area were taken at all study visits.
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Baseline Characteristics
Question Imiquimod 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 58.4 58.7 59.4
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13.1 12.4 12.27
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59 32, 85 58
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31, 89 29, 88
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Gender/Racial descent 69 137 73 2
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37 38 41 721
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1
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unknown
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Lesion location 3 7 5
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2 2 3
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85 175 78
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46 49 44
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90 166 87
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49 46 49
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Trunk neck: 12 (3%) Trunk: anterior lower 5 Trunk: anterior upper 71 Trunk: posterior lower 20 Trunk: posterior upper 70 Lower extremity (excluding foot) 37 Upper extremity (excluding hand) 138 Face: cheek 4 Face: chin 1 Face: forehead 2 Face: nose 0 Trunk
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neck: 7 (4%) Trunk: anterior lower 1 (1%) Trunk: anterior upper 31 (17%) Trunk: posterior lower 13 (7%) Trunk: posterior upper 45 (24%) Lower extremity (excluding foot) 27 (15%) Upper extremity (excluding hand) 58 (31%) Face: cheek 0 (0%) Face: chin 2 (1%) Face: forehead 1 (1%) Face: nose 0 (0%) neck: 9 (5%) Trunk: anterior lower 3 (2%) Trunk: anterior upper 24 (13%) Trunk: posterior lower 14 (8%) Trunk: posterior upper 46 (26%) Lower extremity (excluding foot) 19 (11%) Upper extremity (excluding hand) 59 (33%) Face: cheek 2 (1%) Face: chin 1 (1%) Face: forehead 1 (1%) Face: nose 1 (1%)
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Skin type (Fitzpatrick score) 28 70 29
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15 19 16
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99 155 83
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54 43 46
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48 116 60
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26 32 34
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10 19 7
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5 5 4
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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 185 360 179
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185 360 179
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185 360 179
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185 360 179
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13 16 16
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13 16 16
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178 346 170
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178 346 170
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Lesion extent number of people 100% 100% 100% 100%
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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 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk


18 weeks

N Analyzed 175 346 171
Counts 20 335 29
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk


6 weeks

N Analyzed 185 360 179
Counts 107 129 126
Percentage 58 36 64


18 weeks

N Analyzed 175 360 166
Counts 58 51
Percentage 33 31
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure Imiquimod 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk


6 weeks

N Analyzed 185 179
Counts 30 47
Percentage 16 26
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Imiquimod 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk


6 weeks

N Analyzed 185 179
Counts 11 16
Percentage 6 9
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Imiquimod 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk


6 weeks

N Analyzed 185 179
Counts 6 11
Percentage 3 6
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk


6 weeks

N Analyzed 185 360 179
Counts 52 16 79
Percentage 28.1 4.4 44.1
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure Imiquimod 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk


during tx N/A

N Analyzed 185 360 179
Counts 107 130 115
Percentage 58 36 64




N Analyzed
Counts
Percentage
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure Imiquimod 5x/wk Vehicle 5x/wk or 7x/wk Imiquimod 7x/wk


during tx N/A

N Analyzed 185 360 179
Counts 7 nd 4
Percentage


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). not immediately apparent
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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 Yes Some AEs were not reported for vehicle groups
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Overall, by outcome (judgement - put directly into notes field) Overall low RoB. seems overall 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.