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Study Title and Description

Photodynamic therapy in combination with CO2 laser for the treatment of Bowen's disease.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Photodynamic therapy in combination with CO2 laser for the treatment of Bowen's disease.
Author Cai H., Wang YX., Zheng JC., Sun P., Yang ZY., Li YL., Liu XY., Li Q., Liu W.
Country Department of Dermatology, Air Force General Hospital, PLA, Beijing, 100142, People's Republic of China.
Year 2015
Numbers Pubmed ID: 25899562

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 + CO2 Laser
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2 CO2 Laser
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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 china
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Funding No industry support
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Inclusion criteria having skin BD upon biopsy,
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Exclusion criteria porphyria or photosensitivity were excluded
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N Enrolled/Randomized/Analyzed 18
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18
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18
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Notes/Comments 22 lesions from 18 patients. (11 in study group, 11 in control group)
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... not reported ...
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Percent non-primary (recurrent)
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Secondary size assessment
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Baseline Characteristics
Question ALA-PDT + CO2 Laser CO2 Laser Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 2.62 cm 2.58 cm 52
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0.94 cm 0.86 cm 10
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11 11
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Gender/Racial descent 5 5
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50 62.5
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Lesion location No data entered.
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 10 8
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11 11
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10 8
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11 11
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0 0
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0 0
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10 8
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11 11
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Lesion extent number of people No data entered.
Lesion extent number of people 22 lesions (18 subjects)
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All cases were SCCIS/BOWEN
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Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure ALA-PDT + CO2 Laser CO2 Laser


1 months

N Analyzed 11 11
Counts 3 4
Percentage 27.27 36.37


6 months

N Analyzed 11 11
Counts 1 5
Percentage 9.1 45.45
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure ALA-PDT + CO2 Laser CO2 Laser


na N/A

N Analyzed 10 (subjects) 8 (subjects)
Counts 0 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unsure
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RCT:....Adequate allocation concealment reported Yes
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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).
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RCT.....Is the treatment effect by Intention to treat? Unsure study states: "patients randomly assigned to two groups according to their hospital identification number" did not mention a specific computer generator
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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 No no table for adverse events; study loosely describes ae in the body of the text for study arm
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Overall, by outcome (judgement - put directly into notes field) low for efficacy; high 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
Guideline Used Overall Rating