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Study Title and Description

The effect of an intralesional sustained-release formulation of interferon alfa-2b 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 an intralesional sustained-release formulation of interferon alfa-2b on basal cell carcinomas.
Author Edwards L., Tucker SB., Perednia D., Smiles KA., Taylor EL., Tanner DJ., Peets E.
Country University of Arizona College of Medicine, Tucson.
Year 1990
Numbers Pubmed ID: 2383027

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


Extraction Form: Comparative studies
Arms
Number Title Description Comments
1 Interferon alfa-2b, 30 million IU
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2 Interferon alfa-2b, 10 million IU
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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 otherwise healthy patients age 35-65; 1 clinically typical, sharply defined basal cell carcinoma with clearly visible margins, ranging in size from 0.5 to 1.5 cm for nodular tumors or 2 cm for superficial lesions in largest diameter, per patient.
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Exclusion criteria Morpheic basal cell carcinomas, recurrent cancers, deeply invasive lesions, periorificial tumors, and central facial basal cell carcinomas; serious or debilitating illness, a history of thromboembolic or cardiovascular disease, radiation therapy to the test site area, or a history of arsenic ingestion. Pregnancy, breast-feeding, and immunosuppression as a result of medication or illness, nonsteroidal anti-inflammatory medications
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N Enrolled/Randomized/Analyzed 65
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65
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63
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Notes/Comments
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Method of diagnosis ... Describe Biopsy/pathologic confirmation ... confirmatory diagnostic shave or punch skin biopsy that removed less than 25% of the lesion
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Preoperative assessment of clinical size of the tumor ... visual ... The size and a clinical description of each basal cell carcinoma were recorded. The lesion was then photographed.
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Percent non-primary (recurrent) 0
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Secondary size assessment
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Baseline Characteristics
Question Interferon alfa-2b, 30 million IU Interferon alfa-2b, 10 million IU Total Comments
AnswerFollow-up AnswerFollow-up AnswerFollow-up
Continuous baselines 35, 65
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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 32 33
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32 33
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2 33
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dropped out after the first injection due to side effects 33
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30 33
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32 33
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32
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2
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30
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Lesion extent number of people 15 16
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15 17
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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 alfa-2b, 30 million IU Interferon alfa-2b, 10 million IU


16 weeks

N Analyzed 30 33
Counts 6 16
Outcome: Lack of histological clearance      Population: Superficial
Time Point Measure Interferon alfa-2b, 30 million IU Interferon alfa-2b, 10 million IU


16 weeks

N Analyzed 15 16
Counts 3 9
Outcome: Lack of histological clearance      Population: Nodular
Time Point Measure Interferon alfa-2b, 30 million IU Interferon alfa-2b, 10 million IU


16 weeks

N Analyzed 15 17
Counts 3 7


Quality Dimensions
Dimension Value Notes Comments
RCT:....Adequate generation of a randomized sequence reported Unsure not reported; randomization done in blocks by lesion type (superficial or nodular)
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RCT:....Adequate allocation concealment reported Unsure not reported
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RCT:....Adequate blinding of PATIENTS reported Unsure not reported
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RCT:....Adequate blinding of PROVIDERS reported Unsure not reported
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ALL....Adequate blinding of OUTCOME ASSESSORS reported Unsure not reported
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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). Adverse events and cosmetic outcomes were not presented by arm.
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RCT.....Is the treatment effect by Intention to treat? Yes
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ALL....Group similarity at baseline. Unsure baseline data not reported
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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) This paper lacks detail on study design, so it is unclear whether it was properly conducted 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.