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Study Title and Description

A randomized study of minimal curettage followed by topical photodynamic therapy compared with surgical excision for low-risk nodular basal cell carcinoma.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title A randomized study of minimal curettage followed by topical photodynamic therapy compared with surgical excision for low-risk nodular basal cell carcinoma.
Author Berroeta L., Clark C., Dawe RS., Ibbotson SH., Fleming CJ.
Country -- Not Found --
Year 2007
Numbers Pubmed ID: 17573890

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 PDT
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2 excision
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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 United Kingdom
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Funding No industry support
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Inclusion criteria <= 2 cm, well-define, nodular BCC on anatomically noncritical sites
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Exclusion criteria < 18 years old; pregnancy; photosensitivity; morphoeic BCCs; high-risk site; recurrent BCCs; immunodeficiency; size > 2 cm.
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N Enrolled/Randomized/Analyzed 31
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31
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31
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Notes/Comments
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Method of diagnosis ... Describe Other ... not reported
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Preoperative assessment of clinical size of the tumor ... visual ... well defined <=2 cm
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question PDT excision Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 72
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50-89
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Gender/Racial descent No data entered.
Lesion location No data entered.
Skin type (Fitzpatrick score) No data entered.
Number of lesions per patient No data entered.
Previous treatments No data entered.
Immunocompromized status 0
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0
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Number of patients/lesions 21 19 31
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21 19 40
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8 4 31
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21 19 40
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40
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31
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40
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Lesion extent number of people 21 19 40
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Lesion extent number of people No data entered.



Results & Comparisons


Results Data
Outcome: Lack of clinical clearance      Population: All Participants Between-Arm Comparisons
Time Point Measure PDT excision Comparison Measure excision vs. PDT


1 years

N Analyzed 21 19 Risk Difference (RD) 17%
Counts 8 4 95% CI low -11
95% CI high 45
P-Value 0.24




N Analyzed
Counts




N Analyzed
Counts
Outcome: Adverse events: pain      Population: All Participants Between-Arm Comparisons
Time Point Measure PDT excision Comparison Measure excision vs. PDT


0 hours

N Analyzed 21 19 P-Value 0.0013
Median 5 0


1 hours

N Analyzed 21 19 P-Value 0.0041
Median 5 0


3 hours

N Analyzed 21 19
Median 0 0


6 hours

N Analyzed 21 19
Median 0 0


24 hours

N Analyzed 21 19
Median 0 0


48 hours

N Analyzed 21 19
Median 0 0


1 weeks

N Analyzed 21 19
Median 0 0
Outcome: Cosmetic outcome (continuous)      Population: All Participants Between-Arm Comparisons
Time Point Measure PDT excision Comparison Measure excision vs. PDT


3 months

N Analyzed 21 19 P-Value 0.42
Mean 1.94 2.07 95% CI low 0.21
95% CI high 0.48
Outcome: Cosmetic outcome (continuous)      Population: All Participants Between-Arm Comparisons
Time Point Measure PDT excision Comparison Measure excision vs. PDT


3 months

N Analyzed 21 19 P-Value 0.23
Mean 2.23 2.53 95% CI low 0.20
95% CI high 0.81


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
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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). Yes Said they measured at multiple timepoints but only reported 1 year
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. No Data
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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 Yes
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Overall, by outcome (judgement - put directly into notes field) Overall moderate 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
Guideline Used Overall Rating