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Study Title and Description

A randomized trial comparing methyl aminolaevulinate photodynamic therapy with and without Er:YAG ablative fractional laser treatment in Asian patients with lower extremity Bowen disease: results from 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 randomized trial comparing methyl aminolaevulinate photodynamic therapy with and without Er:YAG ablative fractional laser treatment in Asian patients with lower extremity Bowen disease: results from a 12-month follow-up.
Author Ko DY., Kim KH., Song KH.
Country Skin Cancer Center, Department of Dermatology, College of Medicine, Dong-A University, Dong dae sin-dong, Seo-gu, Busan, 602-715, Korea.
Year 2014
Numbers Pubmed ID: 24102369

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Er:YAG AFL PDT
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2 MAL-PDT
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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 Korea
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Funding No industry support
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Inclusion criteria Korean ≥ 18 years with biopsy-confirmed Bowen's Disease lesions on the lower extremities with least two comparable symmetrical lesions of similar severity and no more than a twofold difference in number of lesions between the right and left sides.
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Exclusion criteria porphyria, known allergies to the MAL cream or lidocaine, pregnancy, lactation, any active systemic infectious disease, immunosuppressive treatment, personal history of malignant melanoma, tendency towards melasma or keloid formation, prior treatment of the lesions within 4 weeks, and any indication of poor compliance.
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N Enrolled/Randomized/Analyzed 21
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19
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18
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Notes/Comments within patient randomization
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... visual ... photographed, mapped and numbered
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Percent non-primary (recurrent) NR
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Secondary size assessment photographed at 1 week, 3 months, and 1 year
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Baseline Characteristics
Question Er:YAG AFL PDT MAL-PDT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 68.9 68.9
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13.2 13.2
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35 29
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32 actual 26 actual
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Gender/Racial descent 11 11
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52.4 52.4
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of enrolled, not actual of enrolled, not actual
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0 0
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0 0
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0 0
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0 0
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21 21
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100 100
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korean korean
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Lesion location 35 (32 actual) 29 (26 actual)
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100 100
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Skin type (Fitzpatrick score) 2 2
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9.5 9.5
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15 15
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71.4 71.4
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4 4
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19.1 19.1
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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 protocol violation 21
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21 na
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na 19
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19 na
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na 1
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1 protocol violation
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18 18
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32 26
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Lesion extent number of people No data entered.
Lesion extent number of people 35 (32 actual) 29 (26 actual)
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Results & Comparisons


Results Data
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


12 months

N Analyzed 19 19
Counts 1 6
Percentage 6.7 31.6
Outcome: Adverse events: other      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


throughout study period N/A

N Analyzed 18 18
Counts 0 0
Percentage 0 0
Outcome: Adverse events: scarring      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


throughout study period N/A

N Analyzed 18 18
Counts 0 0
Percentage 0 0
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


3 months

N Analyzed 32 26
Counts 2 7


12 months

N Analyzed 32 26
Counts 4 13
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


12 months

N Analyzed 18 18
Counts 16 17
Percentage 90.6 92.3
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


during illumination N/A

N Analyzed 18 patient 18 patients
Counts 18 18
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


throughout course of treatment. N/A

N Analyzed 18 subjects 18 subjects
Counts 18 18
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


throughout course of treatment. N/A

N Analyzed 18 subjects 18 subjects
Counts 0 0
Outcome: Adverse event: infection      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


throughout course of treatment. N/A

N Analyzed 18 subjects 18 subjects
Counts 0 0
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Er:YAG AFL PDT MAL-PDT


throughout study period N/A

Mean 4.857 4.300
SD 2.035 1.767
N Analyzed 19 19


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unsure
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RCT:....Adequate allocation concealment reported No
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RCT:....Adequate blinding of PATIENTS reported No
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RCT:....Adequate blinding of PROVIDERS reported Unsure
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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). not immediately apparent
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RCT.....Is the treatment effect by Intention to treat? Unsure ITT population was 19. they had one dropout (unclear how many lesions) who violated protocol and counted as treatment failure. bc the exact number of lesions randomized for the 19 pts was not abailable for ITT eval, pp was used for data extraction.
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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 Yes
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Overall, by outcome (judgement - put directly into notes field) overall seems like a decent paper
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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