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Anti-metabolites

5-Fluorouracil + Calcipotriene Cream for Skin Cancer

Phase 2 & 3
Recruiting
Led By Bilal Fawaz, MD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits
Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

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.

Who is the study for?
This trial is for English-speaking adults with low-risk skin cancers (sBCC or SCCis) on certain body parts, who haven't had treatment yet and aren't good candidates for surgery. They must be willing to follow the study plan and attend follow-ups. Women of childbearing age need a negative pregnancy test before starting and must use birth control during the study.Check my eligibility
What is being tested?
The trial compares two creams: one with just 5-fluorouracil, an FDA-approved treatment, against a mix of 5-fluorouracil and calcipotriene. The goal is to see if the combo cream can clear cancer in a shorter time (7-14 days). Participants will be checked over three years to see if their skin cancer has been treated successfully.See study design
What are the potential side effects?
Possible side effects include skin irritation, redness, burning sensation where the cream is applied, increased sensitivity to sunlight leading to sunburns more easily than usual, changes in skin color at the application site, itching or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am willing to follow all study requirements and attend all follow-up visits.
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I have a skin cancer diagnosis on sensitive areas and cannot or do not wish to undergo surgery.
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My cancer lesions are more than 2 cm apart from each other.
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clearance rate of cancer lesions at 3 months
Clearance rate of cancer lesions at 3 years
Secondary outcome measures
Day of worst redness
Participant compliance with treatment
Participant satisfaction with treatment
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Combination cream of 5-fluorouracil and calcipotrieneExperimental Treatment1 Intervention
Participants randomized to this group will receive treatment with the combination cream consisting of 5-fluorouracil and calcipotriene twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.
Group II: 5-fluorouracil creamActive Control1 Intervention
Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
452 Previous Clinical Trials
9,941,449 Total Patients Enrolled
Bilal Fawaz, MDPrincipal InvestigatorDermatology, Boston University School of Medicine

Media Library

5-Fluorouracil (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05381597 — Phase 2 & 3
Basal Cell Carcinoma Research Study Groups: Combination cream of 5-fluorouracil and calcipotriene, 5-fluorouracil cream
Basal Cell Carcinoma Clinical Trial 2023: 5-Fluorouracil Highlights & Side Effects. Trial Name: NCT05381597 — Phase 2 & 3
5-Fluorouracil (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05381597 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
~90 spots leftby Jun 2025