Combination cream of 5-fluorouracil and calcipotriene for Carcinoma in Situ

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Boston Medical Center Dermatology Clinic, Boston, MA
Carcinoma in Situ+5 More
Combination cream of 5-fluorouracil and calcipotriene - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The investigators will compare the application of two different creams for the treatment of low-risk skin cancers-superficial basal cell carcinoma (sBCC) and squamous cell carcinoma in situ (SCCis). 5-Fluorouracil cream is currently FDA approved for the treatment of superficial basal cell carcinoma and is routinely used by dermatologists across the country and at Boston Medical Center (BMC) for SCCis. The normal treatment regimen is 4 weeks of the 5-fluorouracil cream for both skin cancers. The application of a compounded cream consisting of 1:1 ratio 5-fluorouracil with calcipotriene will be tested. This combination cream has been shown to clear pre-skin cancers called actinic keratoses and prevent future skin cancers from developing. This combination cream for 7-14 days to see if this shorter treatment course provides clearance of the 2 types of skin cancer. This combination cream is successfully used in this manner to treat other subtypes of related skin cancers. This will be a pilot study with The primary endpoint for this pilot randomized single blinded clinical trial will be the response to treatment (yes versus no). The lesions will be assessed clinically for clearance of cancer, as would normally be done and is consistent with how comparable studies have assessed clearance. Participants will be followed closely afterwards for three years with visits at 6 months, which does not vary from standard practice. If the lesions are not clear of cancer or equivocal clinically, the lesions will be re-biopsied and normal standard of care procedure will take place.

Eligible Conditions

  • Carcinoma in Situ
  • Superficial Basal Cell Carcinoma
  • Squamous cell carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma in Situ

Study Objectives

2 Primary · 12 Secondary · Reporting Duration: 3 years

1 year
Recurrence rate of cancer lesions at 1 year
3 months
Clearance rate of cancer lesions at 3 months
Day of worst redness
Participant compliance with treatment
Participant satisfaction with treatment
Percent of participants that experience pain during treatment
Percent of participants that experience redness during treatment
Percent of participants who experienced scaling/flaking
Percent of participants who experienced skin burning
Percent of participants who experienced skin itching
Severity of pain during treatment
Severity of redness during treatment
3 years
Clearance rate of cancer lesions at 3 years
Recurrence rate of cancer lesions at 3 years

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Carcinoma in Situ

Trial Design

2 Treatment Groups

5-fluorouracil cream
1 of 2
Combination cream of 5-fluorouracil and calcipotriene
1 of 2
Active Control
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Combination cream of 5-fluorouracil and calcipotriene · No Placebo Group · Phase 2 & 3

Combination cream of 5-fluorouracil and calcipotriene
Drug
Experimental Group · 1 Intervention: Combination cream of 5-fluorouracil and calcipotriene · Intervention Types: Drug
5-fluorouracil cream
Drug
ActiveComparator Group · 1 Intervention: 5-fluorouracil cream · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Closest Location: Boston Medical Center Dermatology Clinic · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Carcinoma in Situ
0 CompletedClinical Trials

Who is running the clinical trial?

Boston UniversityLead Sponsor
410 Previous Clinical Trials
10,023,528 Total Patients Enrolled
Bilal Fawaz, MDPrincipal InvestigatorDermatology, Boston University School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A woman of childbearing potential must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment
You are willing to undergo all protocol requirements and attend study-specific follow up clinic visits in addition to routine follow up visits.
Participants may have multiple lesions enrolled in the study so long as the individual lesions are greater than 2 cm from each other.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.