← Back to all trials
Not Yet Recruiting
NCT07794059
5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses
Conditions: Actinic Keratoses
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 96
Sponsor: Cedars-Sinai Medical Center
Location: Cedars-Sinai Medical Center Los Angeles California
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.
Eligibility Criteria
Inclusion Criteria:
* Individuals 18 years old or older are included
* Presence of 4 to 15 clinically visible and discrete actinic keratoses in a 100-cm2 contiguous area on the face, non-hair bearing scalp, or the upper extremities (including the hand).
* Solid organ transplantation (kidney, lung, heart, liver, and/or pancreas) on immunosuppressive medications for at least one year prior to the start of the study
Exclusion Criteria:
* Active skin cancer
* Recent use of field cancerization within the preceding 12 months in the field of treatment
* Use of nicotinamide or vitamin A derivatives (which are systemic agents intended for NMSC prevention).
* Any records flagged "break the glass" or "research opt out."
* Allergy or hypersensitivity to 5-Fluorouracil or Calcipotriene or inactive components of compounded product
* Pregnant and breastfeeding patients
* Allergy to peanut as some formulation of 5FU may contain peanut oil.
* Allergy or hypersensitivity to Trolamine-NF, PenDerm Cream Base, and Propylene Glycol
Source: ClinicalTrials.gov (NCT07794059). StuddyBuddy aggregates publicly available trial information.