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Study Title and Description

The effect of intralesional interferon gamma on basal cell carcinomas.



Key Questions Addressed
1 Comparison of interventions
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Primary Publication Information
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TitleData
Title The effect of intralesional interferon gamma on basal cell carcinomas.
Author Edwards L., Whiting D., Rogers D., Luck K., Smiles KA.
Country Department of Internal Medicine (Dermatology), University of Arizona Medical Center, Tucson.
Year 1990
Numbers Pubmed ID: 2107219

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 interferon gamma, 0.01
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2 interferon gamma, 0.05
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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. Unclear
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Country/Region U.S.
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Funding Industry supplied materials
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Inclusion criteria clinically typical, sharply defined basal cell carcinomas easily excisable at the end of the study
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Exclusion criteria any serious or debilitating illness, history of thromboembolic phenomena, or cardiovascular disease, received radiation therapy to the test site area or who had a history of arsenic ingestion, pregnant or nursing women, patients who were immunosuppressed, patients taking nonsteroidal anti-inflammatory medications
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N Enrolled/Randomized/Analyzed 29
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29
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29
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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 ... visual ... at randomization, immediately before treatment and at the beginning of each treatment week
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Percent non-primary (recurrent) NR
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Secondary size assessment
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Baseline Characteristics
Question interferon gamma, 0.01 interferon gamma, 0.05 Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 37, 69
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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 No data entered.
Number of patients/lesions 15 14
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15 14
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15 14
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15 14
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0 0
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0 0
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15 14
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15 14
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Lesion extent number of people 7 8
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8 6
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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 interferon gamma, 0.01 interferon gamma, 0.05


15 weeks

N Analyzed 15 14
Counts 14 7
Outcome: Lack of histological clearance      Population: superficial
Time Point Measure interferon gamma, 0.01 interferon gamma, 0.05


15 weeks

N Analyzed 7 8
Counts 6 4
Outcome: Lack of histological clearance      Population: nodular
Time Point Measure interferon gamma, 0.01 interferon gamma, 0.05


15 weeks

N Analyzed 8 6
Counts 8 3


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unsure not reported; subjects randomized in blocks based on lesion type
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RCT:....Adequate allocation concealment reported Unsure not reported
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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). There appears to be some selective reporting: cosmetic outcomes were only reported in a subset of patients and not by arm, adverse events were not reported by arm. <-seems to be true in all studies
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RCT.....Is the treatment effect by Intention to treat? Yes no drop outs, no crossovers
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ALL....Group similarity at baseline. Unsure no baseline details given
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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 Adverse events were not defined and were not given by arm
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Overall, by outcome (judgement - put directly into notes field) This is an older study and a very short report, so things may have been done right but not adequately reported Moderate to high 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
No quality rating data was found.