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Study Title and Description

Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma: results of two randomized studies.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Photodynamic therapy with methyl aminolevulinate for primary nodular basal cell carcinoma: results of two randomized studies.
Author Foley P., Freeman M., Menter A., Siller G., El-Azhary RA., Gebauer K., Lowe NJ., Jarratt MT., Murrell DF., Rich P., Pariser DM., Oseroff AR., Barnetson R., Anderson C., Kossard S., Gibson LE., Tope WD.
Country Department of Medicine (Dermatology), The University of Melbourne, St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia. peter.foley@svhm.org.au
Year 2009
Numbers Pubmed ID: 20064185

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 methyl-aminolevulinatePDT
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2 placebo 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. Multicenter
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Country/Region U.S. and australia
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Funding Industry funded
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Inclusion criteria 18 years, with primary nodular BCC verified by local histologic exam of 2-3 mm punch biopsy and suitable for a simple excision surgery were enrolled.
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Exclusion criteria Lesions were excluded if they involved the periorbital area, ears, nasaolabial fold; had a diameter of < 6mm (any site) o >15 mm (face or scalp), > 20 mm (extremities or neck), or > 30 mm (trunk); were pigmented, or on biopsy, showed a morpheaform or infiltrating pattern. Patients with porphyria, Gorlin's syndrome, xeroderma pigmentosum, history of arsenic exposure or allergy to MAL, ALA, or excipients of the cream, who had participated in any other investigational study in the previous 30 days or were likely to be poorly compliant, who were pregnant or breast-feeding were excluded. concomitant treatment with any immunosuppressive medication was prohibited.
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N Enrolled/Randomized/Analyzed 131 (160 lesions)
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131 (160 lesions)
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128
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Notes/Comments Three patients did not complete the study combination of 2 rcts/ not complete the study: two patients in the MAL PDT group [one who withdrew consent for excision (he showed a com- plete clinical response with excellent cosmetic outcome and did not want the excision of ‘‘normal’’ skin as he was con- vinced the lesion had cleared) and one who experienced a nontreatment-related serious adverse event (death caused by cholangiocarcinoma before the final assessment)], and one patient in the placebo group (who was lost to follow-up).
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ...
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Percent non-primary (recurrent) 0%
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Secondary size assessment
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Baseline Characteristics
Question methyl-aminolevulinatePDT placebo PDT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 66 67
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28-88 39-88
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8.8mm 9.0 mm
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6mm-20mm 6mm-22mm
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largest lesion diameter largest lesion diameter
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75 75
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Gender/Racial descent 19 13
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28.78 20
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Lesion location 19 23
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25 31
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FACE+SCALP FACE+SCALP
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15 17
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20 23
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41 35
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55 46
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Trunk 32 (43%) Neck 9 (12%) Trunk 34 (45%) Neck 1(1%)
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Skin type (Fitzpatrick score) 27 19
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41 29
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26 28
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39 43
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13 18
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20 28
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III/IV combined in III III/IV combined in 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 66 65
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75 75
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66 65
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75 75
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2 1
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2 1
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study: two patients in the MAL PDT group [one who withdrew consent for excision (he showed a com- plete clinical response with excellent cosmetic outcome and did not want the excision of ‘‘normal’’ skin as he was con- vinced the lesion had cleared) and one who experienced a nontreatment-related serious adverse event (death caused by cholangiocarcinoma before the final assessment)], lost to follow up
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66 65
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75 75
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Lesion extent number of people 66 subjects (75 lesions) 65 subjects (75 lesions)
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure methyl-aminolevulinatePDT placebo PDT


3 after last treatment months

N Analyzed 75 75
Counts 20 55
Outcome: Lack of histological clearance      Population: face/scalp
Time Point Measure methyl-aminolevulinatePDT placebo PDT


3 after last treatment months

N Analyzed 19 23
Counts 3 18
Outcome: Lack of histological clearance      Population: neck
Time Point Measure methyl-aminolevulinatePDT placebo PDT


3 after last treatment months

N Analyzed 9 1
Counts 4 1
Outcome: Lack of histological clearance      Population: trunk
Time Point Measure methyl-aminolevulinatePDT placebo PDT


3 after last treatment months

N Analyzed 32 34
Counts 8 24
Outcome: Lack of histological clearance      Population: extremities
Time Point Measure methyl-aminolevulinatePDT placebo PDT


3 after last treatment months

N Analyzed 15 17
Counts 5 12
Outcome: Lack of histological clearance      Population: lesion diameter <10 mm
Time Point Measure methyl-aminolevulinatePDT placebo PDT


3 after last treatment months

N Analyzed 64 61
Counts 15 43
Outcome: Lack of histological clearance      Population: lesion diameter 10 to > 20 mm
Time Point Measure methyl-aminolevulinatePDT placebo PDT


3 after last treatment months

N Analyzed 11 14
Counts 5 12
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure methyl-aminolevulinatePDT placebo PDT


na N/A

N Analyzed 43 15
Counts 42 14
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure methyl-aminolevulinatePDT placebo PDT


na N/A

N Analyzed 66 65
Counts 12 3
Outcome: Adverse events: other      Population: All Participants
Time Point Measure methyl-aminolevulinatePDT placebo PDT


na N/A

N Analyzed 66 65
Counts 14 4
Outcome: serious adverse events      Population: All Participants
Time Point Measure methyl-aminolevulinatePDT placebo PDT


na N/A

N Analyzed 66 patients 65 patients
Counts 2 patient 4 patients
Outcome: Adverse events: other      Population: All Participants
Time Point Measure methyl-aminolevulinatePDT placebo PDT


na N/A

N Analyzed 66 65
Counts 49 30
Outcome: Adverse events: other      Population: All Participants
Time Point Measure methyl-aminolevulinatePDT placebo PDT


na N/A

N Analyzed 66 65
Counts 49 30


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 Yes
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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). No
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RCT.....Is the treatment effect by Intention to treat? No 3 dropouts (2 in MAL and 1 in placebo) inconsistent and unclearly presented.
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ALL....Group similarity at baseline. Unsure They did note a significant difference btw groups in the distribution of Fitzpatrick skin phototype (p<0.05), largely caused by greater proportion of patients with skin type 1 in the MAL group
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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) low for all outcomes
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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.