Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07794059). StuddyBuddy aggregates publicly available trial information.