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Study Title and Description

Topical methyl aminolaevulinate photodynamic therapy versus cryotherapy for superficial basal cell carcinoma: a 5 year randomized trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Topical methyl aminolaevulinate photodynamic therapy versus cryotherapy for superficial basal cell carcinoma: a 5 year randomized trial.
Author Basset-Seguin N., Ibbotson SH., Emtestam L., Tarstedt M., Morton C., Maroti M., Calzavara-Pinton P., Varma S., Roelandts R., Wolf P.
Country Service de dermatologie, Hôpital Saint-Louis, 1 avenue Claude Vellefaux, 75010 Paris, France. nicole.basset-seguin@sls.aphp.fr
Year 2008
Numbers Pubmed ID: 18693158

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 Cryotherapy 2 freeze thaw cycles
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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 13 centers in 7 european countries
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Funding No industry support
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Inclusion criteria 18 years or older with previously untreated primary superficial BCC lesions suitable for cryotherapy. Diagnosis of primary superficial BCC was confirmed by histology using a 4 mm punch biopsy. Patients with up to 10 eligible lesions were considered for inclusion in the study.Lesions with a diameter of more than 6 mm but less than 15 mm on the face or scalp, of less than 20 mm on the extremities or neck and less than 30 mm on the trunk, which were not pigmented, morpheaform or infiltrating.
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Exclusion criteria excluded patients with xeroderma pigmentosum, porphyria, Gorlin’s syndrome, history of arsenic exposure, allergy to MAL or other topical photosensitizers or excipients of the cream, who had participated in other investigational studies in the last 30 days and pregnant or breast-feeding women. Concomitant treatment with immunosuppressive medication was prohibited.
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N Enrolled/Randomized/Analyzed 120
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118
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115
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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 ... not reported ...
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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 Cryotherapy Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 62 64
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25-86 38-90
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Gender/Racial descent 19 27
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33 47
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58 57
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100 100
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Lesion location 6 4
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6 4
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face/scalp face/scalp
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included with face 20
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included with face 20
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23 74
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22 76
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74
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72
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Skin type (Fitzpatrick score) 3 3
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5 5
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33 36
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57 63
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19 17
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33 30
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3 1
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5 2
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0 0
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0 0
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Number of lesions per patient 38 39
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66 68
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8 8
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14 14
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12 10
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21 18
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 62 58
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62 58
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4 1
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Two patients randomized to treatment with MAL PDT were excluded from the study before treatment as diagnosis of BCC could not be verified by histology. one patient was excluded due to insufficient follow-up of the response assessment and one patient died from causes unrelated to study treatment and had no assessment of response. One patient in the cryo- therapy group withdrew his consent.
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58 57
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103 98
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Lesion extent number of people 103 lesions 98 lesions
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure MAL-PDT Cryotherapy


n/a N/A

N Analyzed 60 58
Counts 40 46
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure MAL-PDT Cryotherapy


n/a N/A

N Analyzed 60 58
Counts 0 0
Outcome: Lack of clinical clearance      Population: All Participants
Time Point Measure MAL-PDT Cryotherapy


3 months

N Analyzed 103 lesions 98 lesions
Counts 3 5
Outcome: Lack of clinical clearance      Population: lesion diameter 5-10mm
Time Point Measure MAL-PDT Cryotherapy


3 months

N Analyzed 44 41
Counts 1 3
Outcome: Lack of clinical clearance      Population: lesion diameter 11-19 mm
Time Point Measure MAL-PDT Cryotherapy


3 months

N Analyzed 43 41
Counts 1 2
Outcome: Lack of clinical clearance      Population: lesion diameter > or = 20 mm
Time Point Measure MAL-PDT Cryotherapy


3 months

N Analyzed 16 16
Counts 1 0
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure MAL-PDT Cryotherapy


1 years

N Analyzed 100 93
Counts 9 12


2 years

N Analyzed 100 93
Counts 17 18


3 years

N Analyzed 100 93
Counts 22 18


4 years

N Analyzed 100 93
Counts 22 18


5 years

N Analyzed 100 93
Counts 22 19
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL-PDT Cryotherapy


3 months

N Analyzed 56 52
Counts 33 24


1 years

N Analyzed 51 48
Counts 26 23


2 years

N Analyzed 42 44
Counts 12 18


3 years

N Analyzed 36 43
Counts 12 22


4 years

N Analyzed 33 42
Counts 9 21


5 years

N Analyzed 32 41
Counts 6 20
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL-PDT Cryotherapy


3 months

N Analyzed 56 52
Counts 31 28


1 years

N Analyzed 51 48
Counts 29 25


2 years

N Analyzed 42 44
Counts 19 22
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL-PDT Cryotherapy


3 months

N Analyzed 56 52
Counts 25 11


1 years

N Analyzed 51 48
Counts 22 14


2 years

N Analyzed 42 44
Counts 23 15
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure MAL-PDT Cryotherapy


3 months

N Analyzed 56 52
Counts 17 2


1 years

N Analyzed 51 48
Counts 20 7


2 years

N Analyzed 42 44
Counts 25 4


3 years

N Analyzed 36 43
Counts 19 5


4 years

N Analyzed 33 42
Counts 19 5


5 years

N Analyzed 32 41
Counts 19 7


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 No
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RCT:....Adequate blinding of PROVIDERS reported No
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Unsure
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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? No
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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 Yes
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Overall, by outcome (judgement - put directly into notes field) low to moderate 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.