5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses

ConditionActinic Keratoses

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorCedars-Sinai Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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."

Trial design

Design model

Single group

Treatments tested in this trial

Combination field therapy with 5-fluorouracil and calcipotriene (5FU/C)
Drug
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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

To assess the clinical efficacy of 5FU/C to treat Actinic Keratoses

Our primary endpoint is the percent change from baseline in total AKs at week 9. Secondary endpoints include complete (100%) and partial (75%) clearance of AKs at week 9. These endpoints mirror prior pivotal trials of 5FU/C and will directly evaluate whether immunosuppression reduces clinical efficacy of 5FU/C to treat AKs.

Time frame

9 Weeks

Sponsors and contacts

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Cedars-Sinai Medical Center

Lead sponsor

The Cleveland Clinic

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: