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Study Title and Description

Photodynamic therapy using topical 5-aminolaevulinic acid vs. surgery for basal cell carcinoma



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Photodynamic therapy using topical 5-aminolaevulinic acid vs. surgery for basal cell carcinoma
Author Cosgarea R, Susan M, Crisan M, Senila S
Country
Year 2012
Numbers Pubmed ID: 22738399

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
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2 surgical excision
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Design Details
Question... Follow Up Answer Follow-up Answer
Publication or abstract? Publication
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Study design Prospective nRCS
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Multicenter etc. Single center
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Country/Region Romania
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Funding No industry support
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Inclusion criteria Men or women older than 18, with a clinical diagnosis of primary BCC, superficial or nodular BCC, with a maximum 3 mm above the skin level
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Exclusion criteria recurrent, pigmented or morpheaform lesions; use of phototoxic ⁄ photosensitive drugs, hypersensitivity to light or ALA cream, pregnant or breastfeeding women
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N Enrolled/Randomized/Analyzed 72
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72
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Notes/Comments matched patient choice design
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... Diagnosis had to be histologically confirmed
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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 surgical excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 65 66
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51, 85 49, 90
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Gender/Racial descent 15 19
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47 47.5
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Lesion location 21 20
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44 43
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face/scalp face/scalp
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3 2
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6 5
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24 24
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50 52
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Skin type (Fitzpatrick score) 3 3
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these numbers do not add up these numbers do not add up
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21 19
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12 13
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1 1
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Number of lesions per patient 21` 33
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these numbers do not add up these numbers do not add up
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7 5
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4
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 32 40
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48 46
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0 0
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0 0
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32 40
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48 46
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Lesion extent number of people 31 29
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64.5 63
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17 17
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35.5 37
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure ALA PDT surgical excision


25 months

N Analyzed 48 46
Counts 2 2
Outcome: Recurrence or relapse      Population: superficial
Time Point Measure ALA PDT surgical excision


25 months

N Analyzed 31 28
Counts 0 1
Outcome: Recurrence or relapse      Population: nodular
Time Point Measure ALA PDT surgical excision


25 months

N Analyzed 17 17
Counts 2 1
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA PDT surgical excision


12 months

N Analyzed 48 46
Counts 37 12
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA PDT surgical excision


12 months

N Analyzed 48 46
Counts 11 28
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA PDT surgical excision


12 months

N Analyzed 48 46
Counts 0 4
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA PDT surgical excision


12 months

N Analyzed 48 46
Counts 0 2
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA PDT surgical excision


12 months

N Analyzed 48 46
Counts 36 11
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA PDT surgical excision


12 months

N Analyzed 48 46
Counts 12 28
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA PDT surgical excision


12 months

N Analyzed 48 46
Counts 0 5
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure ALA PDT surgical excision


12 months

N Analyzed 48 46
Counts 0 2


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported
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RCT:....Adequate allocation concealment reported
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RCT:....Adequate blinding of PATIENTS reported
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RCT:....Adequate blinding of PROVIDERS reported
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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). No
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RCT.....Is the treatment effect by Intention to treat?
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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) Yes Baseline numbers for skin type and # lesions per patient do not add up
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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) moderate to high
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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.