Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
NCT05381597

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

Led by Boston University · Updated on 2025-11-28

200

Participants Needed

1

Research Sites

241 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English-speaking
  • Previously untreated, biopsy-confirmed superficial basal cell carcinoma (sBCC) or squamous cell carcinoma in situ (SCCis) less than 2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia
  • Previously untreated, biopsy-confirmed sBCC or SCCis on the face, hands, feet, or genitalia if surgery is declined or not an option
  • Willingness to follow all study procedures and attend study-specific follow-up visits in addition to regular care
  • Multiple lesions may be enrolled if each is at least 2 cm apart
  • Women of childbearing potential must take a pregnancy test before treatment and use birth control during treatment (including abstinence, birth control pills, IUDs, implants, patches, or vaginal rings)
Not Eligible

You will not qualify if you...

  • Field treatment within 2 cm of the target lesion currently or previously
  • Lesions near the eyes (periorbital area)
  • Previously treated lesions
  • Allergy to any study medication ingredients
  • History of solid organ transplant or current immunosuppression
  • Genetic disorders that increase skin cancer risk
  • Arsenic exposure
  • Cutaneous T-cell lymphoma
  • Radiation therapy at the lesion site currently or previously
  • Pregnant or breastfeeding women
  • Prior psoralen plus ultraviolet A treatment at the lesion site
  • Very high risk of death at study start
  • Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
  • High calcium levels or vitamin D toxicity
  • Lesions extending into the mouth, nose, or genital mucosa

AI-Screening

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Trial Site Locations

Total: 1 location

1

Boston Medical Center Dermatology Clinic

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

F

Frederick Gibson, MD

CONTACT

A

Alexandria Riopelle, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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