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5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses
Sponsor: Cedars-Sinai Medical Center
Summary
Combination field therapy with 5-fluorouracil and calcipotriene (5FU/C) has become standard of care among dermatologists for the field treatment of diffuse actinic keratoses (AKs). Data suggest that the addition of calcipotriene elicits a sustained T cell memory allowing for both short and long-term AK clearance. Our objective is to evaluate the efficacy, as well as, document the timing, severity and duration of local cutaneous reactions to topical treatment with 5FU/C for the treatment of AKs.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
96
Start Date
2026-09
Completion Date
2027-09
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Combination field therapy with 5-fluorouracil and calcipotriene (5FU/C)
All patients (n=32 immunocompetent patients and n=64 immunosuppressed, SOTRs) will receive 30g of 5FU/C, compounded by Strive Pharmacy (a FDA-registered 503B outsourcing facility). Solid Organ Transplant Recipients subjects will receive either 4 or 8-days of topical 5FU/C. Duration of treatment with 5FU/C ranges from 4 to 14-days in the clinical dermatology setting, depending on provider experience and judgement, patient compliance, anatomic location, and thickness of AKs.5 Roughly half (n=32) of the SOTRs will receive 4-days of 5FU/C and half (n=32) will receive 8-days of 5FU/C. This study design represents real-world clinical practice.
Locations (2)
Cedars-Sinai Medical Center
Los Angeles, California, United States
Cleveland Clinic
Cleveland, Ohio, United States