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5-Fluorouracil + Calcipotriene Cream for Skin Cancer
Study Summary
This trial will compare the use of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). One cream is 5-Fluorouracil, which is FDA approved, and the other is a compounded cream consisting of a 1:1 ratio of 5-fluorouracil with calcipotriene. The trial will test to see if the shorter treatment course of the compounded cream provides clearance of the 2 types of skin cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am willing to follow all study requirements and attend all follow-up visits.You have a very high risk of dying at the beginning of the study.I have lesions around my eye area.I have a genetic condition that increases my risk for skin cancer.I have had skin cancer treatment close to the current cancer spot.I have been diagnosed with cutaneous T-cell lymphoma.I have had treatments on my lesions before.I am not pregnant or breastfeeding.I have a deficiency in the DPD enzyme.My condition affects the mouth, nose, or genital areas.You are allergic to any of the ingredients in the study medication.I have a skin cancer diagnosis on sensitive areas and cannot or do not wish to undergo surgery.My cancer lesions are more than 2 cm apart from each other.I have a skin cancer diagnosis that hasn't been treated and is smaller than 2 cm, not on my hands, feet, or private areas.I have been exposed to arsenic.I have had an organ transplant or am currently on immunosuppressants.I have had radiation therapy on the skin cancer area.I have had PUVA therapy at the affected site.
- Group 1: Combination cream of 5-fluorouracil and calcipotriene
- Group 2: 5-fluorouracil cream
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Can people with the required medical conditions participate in this trial right now?
"The latest information on clinicaltrials.gov suggests that this trial is still open to recruiting patients. The original posting date for the trial was October 15th, 2022 and there has been one update since then on November 9th, 2022."
How many people are being given the chance to participate in this clinical trial?
"That is correct. The listing on clinicaltrials.gov indicates that the study is open for recruitment and has been since October 15th, 2020. The most recent edit was made on November 9th, 2020. They are looking for 200 individuals to participate at 2 sites."
What are the main goals of this clinical trial?
"The primary outcome of this study is the clearance rate of cancer lesions at 3 years. Secondary outcomes include the percent of participants that experience pain during treatment, defined as based on responses to an investigator-developed survey completed by each participant within 5 days of treatment completion, and the number of participants with scores of 2 or higher divided by all participants; the percent of participants that experience redness during treatment, defined as based on responses to an investigator developed survey completed by each participant within 5 days after treatment completion, and the number of participants with scores or 2 or higher divided by all participants; and day of worst redness, defined as for"
Who else is applying?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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