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Study Title and Description

Fractional laser-mediated photodynamic therapy of high-risk basal cell carcinomas--a randomized clinical trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Fractional laser-mediated photodynamic therapy of high-risk basal cell carcinomas--a randomized clinical trial.
Author Haak CS., Togsverd-Bo K., Thaysen-Petersen D., Wulf HC., Paasch U., Anderson RR., Haedersdal M.
Country Department of Dermatology, D-92, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, DK-2400, Copenhagen NV, Denmark; Wellman Center for Photomedicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, U.S.A.
Year 2015
Numbers Pubmed ID: 24903544

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 MAL PDT
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2 AFXL 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 Denmark
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Funding No industry support
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Inclusion criteria 18 years or older with previously untreated facial tumours. Inclusion criteria were histologically verified nBCC that met at least one of following three criteria defined for high-risk tumours: (i) diameter > 15 mm, (ii) located in the H-zone, (iii) located on severely sun-damaged skin with one or more co-existing actinic lesions requiring treatment
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Exclusion criteria lactating or pregnant women, porphyria, known allergy to MAL cream, Gorlin syndrome, immunosuppressive treatment, Fitzpatrick skin type IV–VI, history of keloid formation and conditions associated with risk of poor compliance
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N Enrolled/Randomized/Analyzed 32
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32
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32
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... histologically verified
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Preoperative assessment of clinical size of the tumor ... visual ... photographed and mapped on a template
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question MAL PDT AFXL MAL PDT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 66 67.5
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57, 74,5 57, 73.5
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8.5 mm 7 mm
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6, 10.5 6, 8
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Gender/Racial descent 6 11
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37.5 68.8
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Lesion location 16 16
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100 100
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Nose 6 (37%) Forehead 5 (31%) Cheek 1 (6%) Oral area 2 (13%) Periorbital area 2 (13%) Nose 9 (56%) Forehead 3 (19%) Cheek 2 (13%) Oral area 1 (6%) Periorbital area 1 (6%)
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Skin type (Fitzpatrick score) 9 11
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56 69
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7 5
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44 31
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Number of lesions per patient 16 16
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100 100
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 16 16
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16 16
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16 16
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16 16
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0 0
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0 0
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16 16
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16 16
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Lesion extent number of people 16 16
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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 MAL PDT AFXL MAL PDT


3 months

N Analyzed 16 16
Counts 2 0
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


6 months

N Analyzed 16 16
Counts 4 1


9 months

N Analyzed 16 16
Counts 6 3


12 months

N Analyzed 16 16
Counts 7 3
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


12 months

N Analyzed 16 16
Counts 7 6
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


3 months

N Analyzed 14 16
Counts 9 11


6 months

N Analyzed 12 15
Counts 6 12


9 months

N Analyzed 10 13
Counts 7 8


12 months

N Analyzed 10 13
Counts 4 8
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


3 months

N Analyzed 14 16
Counts 4 4


6 months

N Analyzed 12 15
Counts 5 2


9 months

N Analyzed 10 13
Counts 1 4


12 months

N Analyzed 10 13
Counts 5 4
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


3 months

N Analyzed 14 16
Counts 1 1


6 months

N Analyzed 12 15
Counts 1 0


9 months

N Analyzed 10 13
Counts 2 0


12 months

N Analyzed 10 13
Counts 1 1
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


3 months

N Analyzed 14 16
Counts 0 0


6 months

N Analyzed 12 15
Counts 0 1


9 months

N Analyzed 10 13
Counts 0 1


12 months

N Analyzed 10 13
Counts 0 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


3 months

N Analyzed 14 16
Counts 8 13


6 months

N Analyzed 12 15
Counts 8 12


9 months

N Analyzed 10 13
Counts 8 10


12 months

N Analyzed 10 13
Counts 7 9
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


3 months

N Analyzed 14 16
Counts 6 2


6 months

N Analyzed 12 15
Counts 4 2


9 months

N Analyzed 10 13
Counts 2 2


12 months

N Analyzed 10 13
Counts 3 3
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


3 months

N Analyzed 14 16
Counts 0 1


6 months

N Analyzed 12 15
Counts 0 1


9 months

N Analyzed 10 13
Counts 0 1


12 months

N Analyzed 10 13
Counts 0 1
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL PDT AFXL MAL PDT


3 months

N Analyzed 14 16
Counts 0 0


6 months

N Analyzed 12 15
Counts 0 0


9 months

N Analyzed 10 13
Counts 0 0


12 months

N Analyzed 10 13
Counts 0 0


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
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RCT:....Adequate allocation concealment reported Yes
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RCT:....Adequate blinding of PATIENTS reported No
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RCT:....Adequate blinding of PROVIDERS reported No
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Yes except patient cosmetic outcomes
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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). none immediately obvious
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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) none immediately obvious
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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) low rob
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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.