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Study Title and Description

A clinical study comparing methyl aminolevulinate photodynamic therapy and surgery in small superficial basal cell carcinoma (8-20 mm), with a 12-month follow-up.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title A clinical study comparing methyl aminolevulinate photodynamic therapy and surgery in small superficial basal cell carcinoma (8-20 mm), with a 12-month follow-up.
Author Szeimies RM., Ibbotson S., Murrell DF., Rubel D., Frambach Y., de Berker D., Dummer R., Kerrouche N., Villemagne H.
Country Klinikum der Universit├Ąt, Regensburg, Germany. rolf-markus.szeimies@klinik.uni-regensburg.de
Year 2008
Numbers Pubmed ID: 18624836

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 MAL-PDT
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2 excision
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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 United Kingdom/Germany/Switzerland/Australia
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Funding Industry funded
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Inclusion criteria >= 18 years old; primary sBCC suitable for simple excision surgery; confirmed by histology; no histological evidence of aggressive growth patterns
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Exclusion criteria > 5 eligible lesions; lesions located in nose, nasolabial, or orbial areas; lesions with largest diameter less than <8 mm or >20 mm; recurrent lesions; lesions located in severely sun-damaged skin where surgery was not suitable due to frequent recurrence/occurrence of other BCCs in the same area; lesions located close to or involving a scar of SCC; pigmented, morpheaform or infiltrating lesions on the treated area; at risk in terms of precautions, warnings, and contraindications as indicated in MAL-PDT package insert; pregnant or breastfeeding women.
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N Enrolled/Randomized/Analyzed 196
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196
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196
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... biopsy at screening
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question MAL-PDT excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 64.5 63.1 63.8
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12.7 13.9 13.3
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33, 85 31, 92 31, 92
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12.5 12.6
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3..7 3.7
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1.4 1.4
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0.8 0.9
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1, 5 1, 5
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Gender/Racial descent 36 30 66
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36.0 31.3 33.7
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100 96 196
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100 100 100
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Lesion location 39 33
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28.9 25.0
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81 93
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60 70.5
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face/scalp 15 11.1 face/scalp 6 4.5
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 79 77
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79 80.2
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 100 96 196
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100 96 196
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13 10 23
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100 96 196
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128 118 246
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128 118 246
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10 1 11
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118 117 235
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Lesion extent number of people 100 96 196
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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 MAL-PDT excision


3 months

N Analyzed 128 118
Counts 10 1
Percentage 7.8 0.8
Outcome: Lack of clinical clearance      Population: face/scalp
Time Point Measure MAL-PDT excision


3 months

N Analyzed 15 4
Counts 0 0
Percentage 0 0
Outcome: Lack of clinical clearance      Population: trunk/neck
Time Point Measure MAL-PDT excision


3 months

N Analyzed 76 83
Counts 7 1
Percentage 8.2 1.2
Outcome: Lack of clinical clearance      Population: extremities
Time Point Measure MAL-PDT excision


3 months

N Analyzed 37 31
Counts 3 0
Percentage 8.1 0
Outcome: Lack of clinical clearance      Population: 7-14 mm
Time Point Measure MAL-PDT excision


3 months

N Analyzed 85 70
Counts 7 1
Percentage 8.2 1.4
Outcome: Lack of clinical clearance      Population: 15-20 mm
Time Point Measure MAL-PDT excision


3 months

N Analyzed 43 43
Counts 3 0
Percentage 7 0
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 118 117
Counts 11 0
Percentage 9.3 0
Outcome: Lack of clinical clearance      Population: face/scalp
Time Point Measure MAL-PDT excision


12 months

N Analyzed 15 4
Counts 4 0
Percentage 26.7 0
Outcome: Lack of clinical clearance      Population: trunk/neck
Time Point Measure MAL-PDT excision


12 months

N Analyzed 69 82
Counts 3 0
Percentage 4.3 0
Outcome: Lack of clinical clearance      Population: extremities
Time Point Measure MAL-PDT excision


12 months

N Analyzed 34 31
Counts 4 0
Percentage 11.8 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 100 96
Counts 0 3
Percentage 0 3.1
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 100 96
Counts 2 1
Percentage 2 1
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 100 96
Counts 31 0
Percentage 31 0
Outcome: Adverse events: skin irritation      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 100 96
Counts 0 3
Percentage 0 3.1
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 83 86
Counts 77 44
Percentage 92.8 51.2
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 100 96
Counts 37 14
Percentage 37 14.6
Outcome: Adverse event: infection      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 100 96
Counts 0 5
Percentage 0 5.2
Outcome: Adverse events: Any serious/severe      Population: All Participants
Time Point Measure MAL-PDT excision


12 months

N Analyzed 100 96
Counts 0 1
Percentage 0 1


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 No
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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).
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RCT.....Is the treatment effect by Intention to treat? Unsure per protocol analysis
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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 No
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Overall, by outcome (judgement - put directly into notes field) Overall low to moderate RoB
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes some outcomes
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Quality Rating
No quality rating data was found.