5-Fluorouracil and Calcipotriene for Treatment of Low Grade Skin Cancer
NCT ID: NCT05381597
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2022-10-15
2027-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Combination 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.
5-fluorouracil cream
Participants randomized to this group will receive treatment with 5-fluorouracil cream twice a day for 28 days.
5-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.
Interventions
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Combination 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.
5-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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having a previously untreated, biopsy-proven Superficial Basal Cell Carcinoma (sBCC) or Squamous Cell Carcinoma in Situ (SCCis) of the skin \<2 cm on the scalp, trunk, neck, or extremities, excluding hands, feet, and genitalia
* Having a previously untreated, biopsy-proven sBCC or SCCis on the face, hands, feet, and genitalia who decline surgery or are otherwise not surgical candidates
* 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
* If a woman is of childbearing potential, the participant must be willing to take a pregnancy test before starting treatment and be on some form of birth control while receiving treatment. Birth control can include abstinence, oral contraceptive pill, intrauterine device, implanted birth control device, birth control patch, or the vaginal ring. The patient does not need to be on any form of birth control after they end therapy.
Exclusion Criteria
* Periorbital lesions
* Lesions that have been previously treated
* Known allergy to any of the study medication ingredients
* History of solid organ transplant or current immunosuppression
* Genetic disorders associated with high skin cancer risk
* Arsenic exposure
* Cutaneous T-cell lymphoma
* Current or prior radiation therapy at the site of the sBCC or SCCis
* Women who are pregnant or currently breastfeeding
* Prior psoralen plus Ultraviolet light (UVA) treatment at the site
* Very high mortality risk at the start of the study
* Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
* Demonstrated hypercalcemia or evidence of vitamin D toxicity
* Lesions that extend into the oral, nasal or genital mucosa
18 Years
ALL
No
Sponsors
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Boston University
OTHER
Responsible Party
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Principal Investigators
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Bilal Fawaz, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology, Boston University School of Medicine
Locations
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Boston Medical Center Dermatology Clinic
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Bilal Fawaz, MD
Role: primary
Frederick Gibson, MD
Role: backup
Other Identifiers
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H-42421
Identifier Type: -
Identifier Source: org_study_id