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Study Title and Description

Single treatment of low-risk basal cell carcinomas with pulsed dye laser-mediated photodynamic therapy (PDL-PDT) compared with photodynamic therapy (PDT): A controlled, investigator-blinded, intra-individual prospective study.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Single treatment of low-risk basal cell carcinomas with pulsed dye laser-mediated photodynamic therapy (PDL-PDT) compared with photodynamic therapy (PDT): A controlled, investigator-blinded, intra-individual prospective study.
Author Čarija A., Puizina-Ivić N., Vuković D., Mirić Kovačević L., Čapkun V.
Country Department of Dermatology, University Hospital Center Split, Split, Croatia; University of Split School of Medicine, Split, Croatia. Electronic address: acarija@kbsplit.hr.
Year 2016
Numbers Pubmed ID: 27516420

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 ALA-PDT + PDL
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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 Croatia
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Funding No industry support
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Inclusion criteria >18 years, >2 BCCs, biopsy proven
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Exclusion criteria lactating and pregnant women, heavily pigmented BCC, diagnosed porphyria
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N Enrolled/Randomized/Analyzed 15
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15
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15
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Notes/Comments Not 100% sure study is an RCT
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... visual ... traced onto graph paper and count squares
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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 ALA-PDT + PDL Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 71 71 4.1
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55, 78 55, 78 2, 9
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255.4 mm2 216 mm2
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209.2 154.3
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Gender/Racial descent 2 2
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13.3 13.3
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Lesion location 1 8
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3.6 23.5
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27 26
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96.4 76.5
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Skin type (Fitzpatrick score) 100% II and III 100% II and III
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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 15 15
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28 34
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15 15
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28 34
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15 15
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28 34
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Lesion extent number of people 22 lesions 28 lesions
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6 lesions 6 lesions
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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 ALA-PDT ALA-PDT + PDL


3 months

N Analyzed 28 34
Counts 6 9
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure ALA-PDT ALA-PDT + PDL


12 months

N Analyzed 22 25
Counts 1 5
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure ALA-PDT ALA-PDT + PDL


during treatment months

N Analyzed 28 34
Mean 1.7 2.6
SD 1.3 0.67
SE
Outcome: Cosmetic outcome (continuous)      Population: All Participants
Time Point Measure ALA-PDT ALA-PDT + PDL


12 months

N Analyzed 28 34
Median 2 2


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No
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RCT:....Adequate allocation concealment reported No
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RCT:....Adequate blinding of PATIENTS reported Unsure
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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? No
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ALL.....Selective Reporting (judgement - put directly into notes field). Yes Only 1 AE reported
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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) No
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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) moderate
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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.