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Study Title and Description

Imiquimod 5% cream as pretreatment of Mohs micrographic surgery for nodular basal cell carcinoma in the face: a prospective randomized 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 pretreatment of Mohs micrographic surgery for nodular basal cell carcinoma in the face: a prospective randomized controlled study.
Author van der Geer S., Martens J., van Roij J., Brand E., Ostertag JU., Verhaegh ME., Neumann HA., Krekels GA.
Country Department of Dermatology, Catharina Hospital Eindhoven, 5623 EJ Eindhoven, the Netherlands. simone.vd.geer@cze.nl
Year 2012
Numbers Pubmed ID: 22385074

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Imiquimod + Mohs
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2 no treatment + 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 Netherlands
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Funding No industry support
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Inclusion criteria above 18 years with a nodular (or nodular and partially superficial) BCC of 1–5 cm in diameter in the face
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Exclusion criteria pregnant women, women who were breastfeeding, patients with recurrent BCC, aggressive growth pattern (squamous, morphoeiform, infiltrative), patients with BCC within 1 cm from the eyes, lips or mucosa of the nose, patients with another skin tumour within 5 cm of the target tumour, and patients with an allergy to imiquimod 5% cream or components of the cream
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N Enrolled/Randomized/Analyzed 70
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70
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70
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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 ... other ... The tumours were marked and then photographed. In addition, a template of the tumour was created with local landmarks, using a permanent marker on translucent paper divided into millimetre squares. A software program (Visitrak; Smith & Nephew, Hull, U.K.) was used to calculate the exact area size in mm2 obtained with the template for all tumour and defect sizes.
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Percent non-primary (recurrent) o
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Secondary size assessment Defect sizes were measured prior to closure of the defects, while patients were lying down with their head and back slightly elevated. Measurement took place after coagulation had taken place and no correction was performed for skin relaxation. The tumours were measured, marked and photographed just before MMS was performed.
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Baseline Characteristics
Question Imiquimod + Mohs no treatment + Mohs Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 69 68
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95%CI 65, 73 95%CI 64, 72
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13 mm 14 mm
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11, 18 12, 18
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95 mmsq 110 mmsq
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60, 173 80, 160
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Gender/Racial descent 13 11
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37 31
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Lesion location 35 35
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100 100
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H-zone 20 (57) Nose 8 (23) Ear 4 (11) Scalp + frontal 8 (23) Face, other regions (cheek, temporal, chin) 15 (43) H-zone 23 (66) Nose 9 (26) Ear 6 (17) Scalp + frontal 5 (14) Face, other regions (cheek, temporal, chin) 15 (43)
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Skin type (Fitzpatrick score) 10 9
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29 26
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23 23
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66 66
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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 35 35
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35 35
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0 0
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35 35
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Lesion extent number of people 35 35
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


12 weeks

N Analyzed 35 35
Counts 33 35
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 1 0


4 weeks

N Analyzed 35 35
Counts 8 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 23 0


4 weeks

N Analyzed 35 35
Counts 26 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 8 0


4 weeks

N Analyzed 35 35
Counts 13 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 7 0


4 weeks

N Analyzed 35 35
Counts 14 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 11 0


4 weeks

N Analyzed 35 35
Counts 10 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 24 0


4 weeks

N Analyzed 35 35
Counts 23 0
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 17 0


4 weeks

N Analyzed 35 35
Counts 20 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 17 0


4 weeks

N Analyzed 35 35
Counts 21 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Imiquimod + Mohs no treatment + Mohs


2 weeks

N Analyzed 35 35
Counts 8 0


4 weeks

N Analyzed 35 35
Counts 18 0


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 No no mention of blinding
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RCT:....Adequate blinding of PROVIDERS reported No no mention of blinding
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ALL....Adequate blinding of OUTCOME ASSESSORS reported No High RoB, no mention of blinding, and only clinical clearance outcome
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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). none that i could spot easily
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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) none
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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) for the outcomes we care about the ROB overall seems moderate
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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
Guideline Used Overall Rating