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Study Title and Description

Similar effectiveness of methyl aminolevulinate and 5-aminolevulinate in topical photodynamic therapy for nodular basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Similar effectiveness of methyl aminolevulinate and 5-aminolevulinate in topical photodynamic therapy for nodular basal cell carcinoma.
Author Kuijpers DI., Thissen MR., Thissen CA., Neumann MH.
Country Department of Dermatology, University Hospital Maastricht, Maastricht, The Netherlands. dku@sder.azm.nl
Year 2006
Numbers Pubmed ID: 16865869

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 ALA-PDT (total) no subgroup stratification, combination of arms 2 and 3
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2 MAL-PDT (total) MAL-PDT + no stratification by subgroup, combination of arms 5+6
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3 ALA-PDT (debulking subgroup) ALA-PDT + allocation to debulking group
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4 ALA-PDT (no debulking subgroup) ALA-PDT + no allocation to debulking group
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5 MAL-PDT (debulking subgroup) MAL-PDT + allocation to debulking group
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6 MAL-PDT (no debulking subgroup) MAL-PDT + no allocation to debulking group
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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 nodular, primary BCC located anywhere but periocular area and hairy scalp; clinical diameter <20 mm.
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Exclusion criteria pigmented BCC; contra-indications to surgery; hypersensitivity to daylight or creams; porphyria; more than 5 BCCs.
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N Enrolled/Randomized/Analyzed 43
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43
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43
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Notes/Comments
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Method of diagnosis ... Describe Other ... not reported
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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 ALA-PDT (total) MAL-PDT (total) ALA-PDT (debulking subgroup) ALA-PDT (no debulking subgroup) MAL-PDT (debulking subgroup) MAL-PDT (no debulking subgroup) Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 8.1 8.4 68.4
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4.12 3.28 73
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39, 87
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8.2
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3.69
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Gender/Racial descent 15
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34.9
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Lesion location 8 8 16
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36.4 38.1 37.2
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forehead/temple+nose/paranasal forehead/temple+nose/paranasal forehead/temple+nose/paranasal
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2 1 3
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9.1 4.8 7.0
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cheek/chin/lips cheek/chin/lips cheek/chin/lips
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0 0 0
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0 0 0
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periorbital periorbital periorbital
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2 3 5
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9.1 14.3 11.6
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ears/periauricular ears/periauricular ears/periauricular
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2 1 3
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9.1 4.8 7.0
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upper+lower upper+lower upper+lower
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8 8 16
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36.4 38.1 37.2
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trunk+neck trunk+neck trunk+neck
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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 22 21 11 11 10 11 39
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22 21 11 11 10 11 43
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22 21 11 11 10 11 39
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43
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39
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43
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Lesion extent number of people 22 21 11 11 10 11 43
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
P-Value
Outcome: Lack of histological clearance      Population: All Participants Between-Arm Comparisons
Time Point Measure ALA-PDT (total) MAL-PDT (total) ALA-PDT (debulking subgroup) ALA-PDT (no debulking subgroup) MAL-PDT (debulking subgroup) MAL-PDT (no debulking subgroup) Comparison Measure ALA-PDT (total) vs. MAL-PDT (total)


9 weeks

N Analyzed 22 21 11 11 10 11 0.924
Counts 6 6 2 4 2 4
Percentage 27.3 28.6 18.2 36.4 20.0 36.4
P-Value P-Value
Outcome: Adverse events: pain      Population: All Participants Between-Arm Comparisons
Time Point Measure ALA-PDT (total) MAL-PDT (total) ALA-PDT (debulking subgroup) ALA-PDT (no debulking subgroup) MAL-PDT (debulking subgroup) MAL-PDT (no debulking subgroup) Comparison Measure ALA-PDT (total) vs. MAL-PDT (total)


1 Treatment

N Analyzed 13 19 0.093
Mean 4.38 2.84
SD 2.57 2.41


2 Treatment

N Analyzed 12 18 0.403
Mean 4.83 3.89
SD 3.21 2.83


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data "randomly assigned" is only mention
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RCT:....Adequate allocation concealment reported Unsure
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RCT:....Adequate blinding of PATIENTS reported Unsure
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RCT:....Adequate blinding of PROVIDERS reported Unsure
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes pathologist was blinded
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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). No no reporting of adverse events other than pain
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RCT.....Is the treatment effect by Intention to treat? Yes no dropouts
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ALL....Group similarity at baseline. Yes seem similar enough
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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) Low RoB for effectiveness outcomes and moderate RoB for AEs
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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.