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Study Title and Description

Single treatment of non-melanoma skin cancers using a pulsed-dye laser with stacked pulses.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Single treatment of non-melanoma skin cancers using a pulsed-dye laser with stacked pulses.
Author Tran HT., Lee RA., Oganesyan G., Jiang SB.
Country Division of Dermatology, University of California, San Diego, La Jolla, CA 92093, USA.
Year 2012
Numbers Pubmed ID: 22511036

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 S1: PDL 15 j/cm2
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2 S2: PDL 7.5 j/cm2
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3 No treatment
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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 US
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Funding NR
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Inclusion criteria Caucasian with Fitzpatrick skin type I and II, 46-84 years old. Superficial, nodular, multicentric BCCs, and SCCIS that measured 0.4–3 cm in size were included in this study
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Exclusion criteria Morpheaform, infiltrating, and recurrent BCCs and invasive SCCs or lesions on the head and neck, hands, feet, and genital areas.
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N Enrolled/Randomized/Analyzed 20
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20
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20
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Preoperative assessment of clinical size of the tumor ... visual ...
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Percent non-primary (recurrent) NR
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Secondary size assessment
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Baseline Characteristics
Question S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 63.5 68 56 12
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88 mm2 105 mm2 94 mm2 62
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12.1 mm2 23.6 mm2 15.2 mm2
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Gender/Racial descent 4 3 3
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57 43 43
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7 7 7
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100 100 100
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Lesion location 1 4 3
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12 50 43
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right forearm 3 upper arm, 1 forearm 2 upper arm, 1 thigh
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7 4 4
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88 50 57
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5 shoulder, 1 abdomen; 1 lower back 1 back, 2 shoulder, 1 chest 1 shoulder, 1 scapula, 1 chest, 1 back
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Skin type (Fitzpatrick score) I and II 100% I and II 100% I and II 100%
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Number of lesions per patient 6 6 7 17
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86 86 100 85
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1 1 3
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14 14 15
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one person had a tumor in control and one in S1
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 7 7 7 20
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8 8 7 23
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7 7 7 20
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8 8 7 23
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0 0 0 0
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0 0 0 0
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7 7 7 20
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8 8 7 23
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Lesion extent number of people 1 4 4
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5 3 2
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1 multifocal multifocal
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multifocal
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Lesion extent number of people 1 1 1
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Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed
Counts
Outcome: Lack of histological clearance      Population: BCC
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed 7 7 6
Counts 6 2 4
Outcome: Lack of histological clearance      Population: SCC
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed 1 1 1
Counts 0 0 1
Outcome: Adverse events: scarring      Population: All Participants
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed
Counts
Outcome: Adverse events: scarring      Population: BCC
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed 7 7 6
Counts 0 0 0
Outcome: Adverse events: scarring      Population: SCC
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed 1 1 1
Counts 0 1 0
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed
Counts
Outcome: Adverse events: Any      Population: BCC
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed 7 7 6
Counts 3 5 0
Outcome: Adverse events: Any      Population: SCC
Time Point Measure S1: PDL 15 j/cm2 S2: PDL 7.5 j/cm2 No treatment


34-44 days

N Analyzed 1 1 1
Counts 1 1 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported No Data
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RCT:....Adequate allocation concealment reported No Data
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RCT:....Adequate blinding of PATIENTS reported Yes
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RCT:....Adequate blinding of PROVIDERS reported No
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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). unclear
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. No groups were not similar at baseline, though the differences were not statistically significant (probably because of the small sample size)
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ALL....Additional Bias: Bias due to problems not covered elsewhere. (judgement - put directly into notes field) Followup times differ within and across groups
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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 to high RoB due to nonsimilar baselines
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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.