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Imiquimod Cream for Basal Cell Carcinoma (B3C Trial)
B3C Trial Summary
This trial will compare Imiquimod vs. placebo cream for preventing basal cell carcinoma of the skin on the face. 1630 Veterans at high risk of BCC will be recruited from 17 VA medical centers.
B3C Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowB3C Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.B3C Trial Design
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Who is running the clinical trial?
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- My current cancer lesion is not from a recurrence after treatment.I have a history of skin lymphoma.My cancerous lesions have not been previously treated with radiation.I am a veteran aged 18 or older.I have a genetic condition that greatly increases my cancer risk.I am a woman who can have children and do not want to use birth control.I have not had specific skin treatments on my face for cancer in the last 2 months.I have had 2 or more BCC lesions in the last 5 years, with at least one on my face, neck, ears, or scalp.I am considered unable to understand and give consent for treatment.I have recently been treated with specific cancer drugs.I have received radiation therapy to my face.I have suspicious skin marks on my face that might be cancer.I have used IMQ therapy on my face within the last year.I cannot communicate in English.I have received a solid organ or bone marrow transplant.I am currently pregnant or breastfeeding.
- Group 1: 5% Imiquimod Cream
- Group 2: Placebo Vehicle Control Cream
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the potential risks associated with using 5% Imiquimod cream?
"There is existing data to support the efficacy of 5% Imiquimod cream, and as this is a Phase 3 trial, it has received a safety score of 3."
What hypothesis is this research trying to test?
"The primary outcome of this study is to assess the Basal Cell Carcinoma (BCC) free time to a new BCC on the face over 3 years. Secondary outcomes include Proportion of participants with a new Basal Cell Carcinoma (BCC) on the face at 1 year by medication compliance status which is defined as Skin exams will occur at baseline & 6 months after randomization. Diagnosis of a new facial BCC will be via biopsy under local anesthesia in an outpatient setting (standard of care). Every facial biopsy will be processed per standard operating procedures, as determined by the blinded clinician for the purposes"
Are volunteers being accepted for this research project at the moment?
"Unfortunately, this study is no longer recruiting patients. It was initially posted on April 1st, 2023 but the most recent update was from January 14th, 2022. There are 2,557 other clinical trials that are still open and actively enrolling participants."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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