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Study Title and Description

Photodynamic Therapy Followed by Mohs Micrographic Surgery Compared to Mohs Micrographic Surgery Alone for the Treatment of Basal Cell Carcinoma: Results of a Pilot Single-Blinded Randomised Controlled Trial.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title Photodynamic Therapy Followed by Mohs Micrographic Surgery Compared to Mohs Micrographic Surgery Alone for the Treatment of Basal Cell Carcinoma: Results of a Pilot Single-Blinded Randomised Controlled Trial.
Author Al-Niaimi F., Sheth N., Kurwa HA., Mallipeddi R.
Country Dermatologic Surgery and Laser Unit, St John's Institute of Dermatology, St Thomas' Hospital, London, UK.
Year 2015
Numbers Pubmed ID: 26157307

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 PDT + MMS
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2 MMS
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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 UK
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Funding NR
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Inclusion criteria >18 years with BCC > 1 x 1 cm2 requiring treatment with MMS
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Exclusion criteria morphoeic, infiltrative and subtypes, a photosensitive skin disorder, hypersensitivity to methyl 5-aminolevulinate, participation in another investigational drug or research study within 30 days of study enrolment, and females of child-bearing potential
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N Enrolled/Randomized/Analyzed 19
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19
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19
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Notes/Comments
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Method of diagnosis ... Describe Other ... nd
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Preoperative assessment of clinical size of the tumor ... visual ...
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Percent non-primary (recurrent) nd
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Secondary size assessment
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Baseline Characteristics
Question PDT + MMS MMS Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 61.4 62.7
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44-84 41-89
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200 mm2 201 mm2
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100-459 mm2 120-408 mm2
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Gender/Racial descent 6 4
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66.7 40
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Lesion location 9 10
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100 100
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Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient 9 10
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Previous treatments No data entered.
Immunocompromized status No data entered.
Number of patients/lesions 9 10
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9 10
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9 10
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9 10
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2 0
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2 0
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7 10
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7 10
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1 AE; 1 no reason given
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Lesion extent number of people 9 10
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Adverse events: Any leading to discontinuation      Population: All Participants
Time Point Measure PDT + MMS MMS


during treatment N/A

N Analyzed 9 10
Counts 1 0
Outcome: Cosmetic outcome (categorical)      Population: All Participants
Time Point Measure PDT + MMS MMS


3 months

N Analyzed 7 10
Counts 7 10
Outcome: Recurrence or relapse      Population: All Participants
Time Point Measure PDT + MMS MMS


6 months

N Analyzed 9 10
Counts 0 0


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 Yes
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ALL.....Incomplete results data: are more than 20% missing for any eligible outcome in any group? Yes
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ALL.....Selective Reporting (judgement - put directly into notes field). 12 month results mentioned in the protocol not given; recurrence rates not given by arm; only 1 AE given
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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)
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ALL (with AE results)....Were reported adverse events (of interest) precisely defined No
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Overall, by outcome (judgement - put directly into notes field) cosmetic outcomes: low recurrence: moderate to high
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ALL.....Incomplete results data: Is there differential missingness (more than 20%) between arms for any eligible outcome? Yes
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Quality Rating
No quality rating data was found.