5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses

Part of paid clinical trials in Los Angeles, California.

Sponsor
Cedars-Sinai Medical Center
Study ID
NCT07794059
Status
Not Yet Recruiting

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Conditions

  • Actinic Keratoses

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

First listed
Aug 31, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
96 participants (estimated)

Primary Outcome Measure

To assess the clinical efficacy of 5FU/C to treat Actinic Keratoses [ Time Frame: 9 Weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90211
Raven Bailey, BS
[email protected]
424-314-0048
Amanda Rosenthal, MD
[email protected]
Nima Gharavi, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Rothy Rim
[email protected]
216-444-7277
Allison Vidimos, MD (PRINCIPAL_INVESTIGATOR)

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