An Observational Study to Determine the Clinical Cure Rate of Therapeutic up Front Shave Removal … (NCT02296970) | Clinical Trial Compass
CompletedNot Applicable
An Observational Study to Determine the Clinical Cure Rate of Therapeutic up Front Shave Removal of Basal Cell Carcinoma of the Skin With Long Term Follow up to Evaluate Recurrence
United States78 participantsStarted 2014-12
Plain-language summary
Determine the effectiveness of a deep shave removal as a definitive treatment for basal cell carcinoma (BCC) without the need for a follow up surgical procedure.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients 18 years or older that are determined by an investigator to have a lesion that is highly likely to be a BCC, less than or equal to 1.0cm in largest diameter, based on clinical examination located in the trunk or extremities, proximal to the wrist and ankles
* Subject is able to give informed consent
* Subject is able to commit to 6 month follow up visit
Exclusion Criteria:
* BCC \> 1cm in diameter on any one axis.
* Immunosuppressed patients
* Subjects with neutropenia
* Organ transplant patients
* Subjects with a life expectancy less than year
* Patients taking immunosuppressive medications, including prednisone at a dose of 10mg or greater with an expected duration greater than 4 weeks, azathioprine, mycophenolate mofetil, cyclosporine, oral Tacrolimus, any Tumor Necrosis Factor (TNF)-alpha inhibitor, ustekinumab, rituximab, or any other medication in the judgement of the investigator could results in clinically meaningful immunosuppression of the subject
* Basal cell carcinomas that have infiltrative or morpheaform characteristics based on clinical examination
* Subjects unable to provide informed consent
* Subjects unable to commit to 6 month follow up
What they're measuring
1
Measurement of clinical cure rate of deep shave removal in the treatment of BCC