RecruitingPhase 2Phase 3NCT05381597

5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer

Combination of 5-Fluorouracil and Calcipotriene in the Treatment of Superficial Basal Cell Carcinomas and Squamous Cell Carcinomas in Situ


Sponsor

Boston University

Enrollment

200 participants

Start Date

Oct 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination cream — 5-fluorouracil (a chemotherapy cream) plus calcipotriene (a vitamin D derivative) — can effectively treat two types of early-stage skin cancer: superficial basal cell carcinoma and squamous cell carcinoma in situ (also called Bowen's disease). **You may be eligible if...** - You have a confirmed, previously untreated spot of superficial basal cell carcinoma or squamous cell carcinoma in situ (Bowen's disease) - Your lesion is smaller than 2 cm and located on the scalp, trunk, neck, or limbs (excluding hands, feet, and genitals) — or on the face/hands/feet if you are not a surgical candidate - You speak English - You are willing to attend follow-up visits - If you are of childbearing age, you are willing to take a pregnancy test **You may NOT be eligible if...** - Your skin lesion has already been treated - Your lesion is larger than 2 cm - You cannot attend required follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCombination cream of 5-fluorouracil and calcipotriene

Apply the cream to the size of the lesion extending to the 0.5 cm area of skin surrounding the lesion.twice a day for 7 days and the treatment can be extended to 14 days based on evaluation at 7 days.

DRUG5-fluorouracil cream

Apply the cream to the size of their lesion extending to the 0.5 cm area of skin surrounding the lesion twice daily for 28 days.


Locations(1)

Boston Medical Center Dermatology Clinic

Boston, Massachusetts, United States

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NCT05381597


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