Cedars-Sinai Medical Center
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.
The primary objectives of this study is to determine whether chronic, systemic immunosuppression alters the short and long-term clinical 9 efficacy of 5FU/C, presumably through decreased CD4+ T cell-mediated immune response in the skin. Our central hypothesis is that SOTRs (Solid Organ Transplant Recipients) exhibit attenuated immunologic activation in response to 5FU/C, resulting in reduced AK clearance and potentially requiring extended duration of treatment compared to their immunocompetent counterparts. To test our hypothesis, we propose the following aims: Aim 1. To assess the clinical…
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…
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.
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