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Study Title and Description

PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title PEP005 (ingenol mebutate) gel for the topical treatment of superficial basal cell carcinoma: results of a randomized phase IIa trial.
Author Siller G., Rosen R., Freeman M., Welburn P., Katsamas J., Ogbourne SM.
Country Siller Medical Pty Ltd, Brisbane, Queensland, Australia. sillermedical@bigpond.com
Year 2010
Numbers Pubmed ID: 20546215

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 vehicle gel, treatment arm A; day 1 and 2 subjects randomized to apply vehicle cream (control) on day 1 and 2.
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2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 subjects randomized to apply 0.0025% ingenol mebutate on days 1 and 2.
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3 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 subjects randomized to apply 0.01% ingenol mebutate on days 1 and 2.
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4 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 subjects randomized to apply 0.05% ingenol mebutate on days 1 and 2.
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5 vehicle gel, treatment arm B- day 1 and 8 subjects randomized to apply vehicle cream (control) on day 1 and 8.
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6 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 subjects randomized to apply 0.0025% ingenol mebutate on days 1 and 8.
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7 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 subjects randomized to apply 0.01% ingenol mebutate on days 1 and 8.
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8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8. subjects randomized to apply 0.05% ingenol mebutate on days 1 and 8.
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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 8 private dermatology clinics Australia
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Funding Industry funded
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Inclusion criteria 18 years or older with one sBCC lesion suitable for surgical excision on the arm, shoulder, chest, face, neck, abdomen, back, leg or scalp. Lesions with a longest pre- and post-biopsy diameter of 4–15 mm and a maximum thickness of 4 mm were eligible.
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Exclusion criteria Exclusion criteria included: women of childbearing potential; recurrent or atypical lesions, immunosuppression, and prior, concomitant or anticipated therapy with the potential to confound the study results.
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N Enrolled/Randomized/Analyzed 60
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60
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60
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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) 0%
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Secondary size assessment
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Baseline Characteristics
Question vehicle gel, treatment arm A; day 1 and 2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 vehicle gel, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8. Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 59
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34-86
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9mm
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4 -15mm
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Gender/Racial descent 16
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26.67%
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60
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100%
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Lesion location 1
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1.67%
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35
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58.33%
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arm+shoulder+leg
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24
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40.00%
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chest+back+neck
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Skin type (Fitzpatrick score) 14
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23.3%
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29
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48.33%
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17
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28.33%
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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 16 16 16 60
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16 16 16 60
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16 16 16 60
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16 16 16 60
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16 16 16 0
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16 16 16 0
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60
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60
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Lesion extent number of people 60
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure vehicle gel, treatment arm A; day 1 and 2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 vehicle gel, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8.


na N/A

N Analyzed 6 8 8 8 6 6 8 8
Counts 0 1 0 0 0 0 0 2
Percentage 0 12.5% 0 0 0 0 0 25%
Outcome: Adverse events: other      Population: All Participants
Time Point Measure vehicle gel, treatment arm A; day 1 and 2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 vehicle gel, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8.


na N/A

N Analyzed 6 8 8 6 8 8 8 8
Counts 0 1 0 0 0 0 0 0
Percentage 0 12.5 0 0 0 0 0 0
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure vehicle gel, treatment arm A; day 1 and 2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 vehicle gel, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8.


85 days

N Analyzed 6 8 8 8 6 8 8 8
Counts 5 7 5 3 6 7 7 7
Percentage 83.33 87.5 62.5 37.5 100 87.5 87.5 87.5
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure vehicle gel, treatment arm A; day 1 and 2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 vehicle gel, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8.


85 days

N Analyzed 6 8 8 8 6 8 8 8
Counts 6 8 6 3 5 7 8 5
Percentage 100 100 75 37.5 83.33 87.5 100 62.5
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure vehicle gel, treatment arm A; day 1 and 2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 vehicle gel, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8.


na N/A

N Analyzed 6 8 8 8 6 8 8 8
Counts 0 3 0 3 0 1 2 2
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure vehicle gel, treatment arm A; day 1 and 2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 vehicle gel, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8.


na N/A

N Analyzed 6 8 8 8 6 8 8 8
Counts 0 0 1 1 0 0 0 0
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure vehicle gel, treatment arm A; day 1 and 2 ingenol mebutate gel, 0.0025%, treatment arm A-days 1 and 2 ingenol mebutate gel, 0.01%, treatment arm A- day 1 and 2 ingenol mebutate gel, 0.05%, treatment arm A-day 1 and 2 vehicle gel, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.0025%, treatment arm B-days 1 and 8 ingenol mebutate, 0.01%, treatment arm B- day 1 and 8 ingenol mebutate gel, 0.05%, treatment arm B-day 1 and 8.


na N/A

N Analyzed 6 8 8 8 6 8 8 8
Counts 0 0 0 0 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 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? Unsure
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ALL.....Selective Reporting (judgement - put directly into notes field).
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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
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Overall, by outcome (judgement - put directly into notes field) low for all outcomes
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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.