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Study Title and Description

Effect of Methyl Aminolevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: A Randomized Clinical Trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Effect of Methyl Aminolevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: A Randomized Clinical Trial.
Author Choi SH., Kim KH., Song KH.
Country Department of Dermatology, College of Medicine, Dong-A University, Busan, Republic of Korea.
Year 2017
Numbers Pubmed ID: 28199463

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 ablative fractional laser-primed MAL- 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 NR
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Inclusion criteria > 18 years with previously untreated microinvasive SCC, tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and difficulty in surgical excision because of health problems
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Exclusion criteria pregnancy or lactation; active systemic infectious disease; other inflammatory, infectious, or neoplastic skin diseases in the treated area; allergy to MAL,other topical photosensitizers, or excipients of the cream; history of photosensitivity; use of immunosuppressive or photosensitizing drugs; participation in any other investigational study in the preceding 30 days; history or indicators of poor compliance. Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis
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N Enrolled/Randomized/Analyzed 45
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45
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40
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... 4-mm punch biopsy specimen
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Preoperative assessment of clinical size of the tumor ... visual ... All the microinvasive SCC lesions were photographed for baseline measurement.
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 76.4 75.1
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6.2 6.2
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11.5 mm 11.8 mm
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3.8 4.1
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Gender/Racial descent 15 13
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71.4 54.6
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Lesion location 16 18
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76.2 75.0
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face or scalp face or scalp
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4 4
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19.0 16.7
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1 2
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4.8 8.3
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Skin type (Fitzpatrick score) 6 7
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28.6 29.1
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12 13
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57.1 54.2
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3 4
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14.3 16.7
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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 21 24
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21 24
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2 3
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2 lost to followup 2 lost to followup; 1 discontinued intervention
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19 21
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Lesion extent number of people No data entered.
Lesion extent number of people 17 18
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81 75
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4 6
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19 25
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Results & Comparisons


Results Data
Outcome: Lack of histological clearance      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


3 months

N Analyzed 19 21
Counts 3 10
Percentage 15.8 47.6


12 months

N Analyzed 19 21
Counts 5 17
Percentage 26.3 80.9


24 months

N Analyzed 19 21
Counts 6 18
Percentage 31.6 85.7
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


12 months

N Analyzed 16 11
Counts 2 7
Percentage 12.5 63.6


24 months

N Analyzed 16 11
Counts 3 8
Percentage 18.8 72.7
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


24 months

N Analyzed 13 3
Counts 10 2




N Analyzed
Counts
Outcome: Adverse events: Any      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


at time of treatment months

N Analyzed 19 21
Counts 19 21
Outcome: Adverse events: pain      Population: All Participants
Time Point Measure Er:YAG ablative fractional laser-primed MAL- PDT MAL-PDT


at time of treatment months

N Analyzed 19 21
Counts 19 21


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Yes
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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 No
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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? 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) 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.