5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses

NCT07794059 | Not Yet Recruiting FDA Drug

• 1 other identifier: STUDY00004901
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Actinic Keratoses

Keywords

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• 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.

  9 Weeks

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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, PenDe

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• The Cleveland Clinic: collaborator

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90211, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Fluorouracil; calcipotriene

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Raven Bailey, BS

CONTACT

713-702-4194; Raven.Bailey@csmns.org

Amanda Rosenthal, MD

CONTACT

Amanda.Rosenthal@cshs.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

US (2)