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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston University
Study ID
NCT05381597
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Squamous Cell Carcinoma in Situ
  • Superficial Basal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Combination cream of 5-fluorouracil and calcipotriene — DRUG
    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.
  • 5-fluorouracil cream — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 15, 2022
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Combination cream of 5-fluorouracil and calcipotriene
    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.
  • Active Comparator: 5-fluorouracil cream
    Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.

Primary Outcome Measure

Clearance rate of cancer lesions at 3 months [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical Center Dermatology ClinicBostonMassachusetts02118
Bilal Fawaz, MD
[email protected]
617-358-9700
Frederick Gibson, MD
[email protected]
(617) 358-9700
Bilal Fawaz, MD (PRINCIPAL_INVESTIGATOR)
Frederick Gibson, MD (SUB_INVESTIGATOR)

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By research site
Boston Medical Center Dermatology Clinic· Boston, MA

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