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Study Title and Description

The effect of topical diclofenac 3% and calcitriol 3 μg/g on superficial basal cell carcinoma (sBCC) and nodular basal cell carcinoma (nBCC): A phase II, randomized controlled trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title The effect of topical diclofenac 3% and calcitriol 3 μg/g on superficial basal cell carcinoma (sBCC) and nodular basal cell carcinoma (nBCC): A phase II, randomized controlled trial.
Author Brinkhuizen T., Frencken KJ., Nelemans PJ., Hoff ML., Kelleners-Smeets NW., Zur Hausen A., van der Horst MP., Rennspiess D., Winnepenninckx VJ., van Steensel MA., Mosterd K.
Country Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands. Electronic address: t.brinkhuizen@mumc.nl.
Year 2016
Numbers Pubmed ID: 27067393

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Diclofenac
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2 Calcitriol
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3 Diclofenac + Calcitriol
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4 No treatment
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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 Industry supplied materials
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Inclusion criteria Patients with histologically proven primary sBCC or (micro) nBCC 4 mm or larger, not located on the face or on the hairy scalp
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Exclusion criteria
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N Enrolled/Randomized/Analyzed 128
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128
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119
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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 ...
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Percent non-primary (recurrent) Standardized photographs of all lesions were taken with a ruler and color card on days 1 and 56.
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Secondary size assessment
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Baseline Characteristics
Question Diclofenac Calcitriol Diclofenac + Calcitriol No treatment Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 63.0/78.5 65.5/68.5 67.5/71 61.5/66
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54, 82 55, 75 60, 79 49, 73
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Superficial/Nodular BCC Superficial/Nodular BCC Superficial/Nodular BCC Superficial/Nodular BCC
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61.7/49.5 mm2 54.2/59.7 mm2 46.7/44.8 mm2 59.7/53.4 mm2
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30.0, 84.4 34.3, 87.6 33.0, 101.3 39.1, 98.4
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Superficial/Nodular BCC Superficial/Nodular BCC Superficial/Nodular BCC Superficial/Nodular BCC
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Gender/Racial descent 8 7 12 12
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25 22 37.5 37.5
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Lesion location 15 19 16 17
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47 59 50 53
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17 13 14 15
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53 41 44 47
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upper extremity 6 lower extremity 9 upper extremity 11 lower extremity 2 upper extremity 11 lower extremity 4 other 1 upper extremity 9 lower extremity 8
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 32 32 32 32 128
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32 32 32 32 128
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0 32 0 32 127
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31 32 1
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1 withdrew just after randomization
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Lesion extent number of people 32 32 16 16
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16 16 16 16
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16 13 15 14
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3 (1 2
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1 micronodular; 2 mixed 1 micronodular; 2 mixed
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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 Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 30 32 31 32
Counts 16 25 19 29
Outcome: Lack of histological clearance      Population: Superficial BCC
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 14 16 16 16
Counts 5 16 9 16
Outcome: Lack of histological clearance      Population: Nodular BCC
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 16 16 15 16
Counts 11 15 10 13
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


during tx N/A

N Analyzed 31 32 32 32
Counts 28 27 28 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


during tx N/A

N Analyzed 31 32 32 32
Counts 8 4 13 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 12 9 12 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 21 20 22 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 11 5 10 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 12 7 10 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 12 9 13 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 11 7 7 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 6 3 4 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 16 11 14 0
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 5 2 5 0
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


8 weeks

N Analyzed 31 32 32 32
Counts 6 2 8 0
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


during tx N/A

N Analyzed 31 32 32 32
Counts 2 0 1 0
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure Diclofenac Calcitriol Diclofenac + Calcitriol No treatment


during tx N/A

N Analyzed 31 32 32 32
Counts 0 0 0 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
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RCT:....Adequate blinding of PROVIDERS reported No
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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. No superficial not similar, nodular similar enough
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Some of the numbers don't add up
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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) Overall low to moderate RoB, seems 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.