5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
Status:
Not yet recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
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.