A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses

NCT06851507 | Recruiting Phase 3 DMC

• 2 other identifiers: 2024-2003NCI-2025-01497
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to compare the effects of topical fluorouracil alone to topical fluorouracil plus topical calcipotriene in patients with multiple actinic keratoses. "Topical" means the medication is applied directly to the skin.

Conditions

Multiple Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (2)

Treatment with Fluorouracil and Calcipotriene

EXPERIMENTAL

Participants will screened and enrolled during a standard-of-care clinical dermatology visit. Participants will be randomized in between treatment with topical 5-FU twice daily for 2-3 weeks

Drug: Fluorouracil/Calcipotriene

Treatment with Fluorouracil

EXPERIMENTAL

Participants will screened and enrolled during a standard-of-care clinical dermatology visit. Participants will be randomized in between treatment with topical 5-FU twice daily for 2-3 weeks

Drug: Fluorouracil 5-FU

Interventions

Fluorouracil 5-FU DRUG

Participants in the fluorouracil arm will apply fluorouracil twice daily for 2-3 weeks (depending on body area).

Treatment with Fluorouracil

Fluorouracil/Calcipotriene DRUG

Participants in the fluorouracil/calcipotriene will apply fluorouracil/calcipotriene twice daily for 4 days to the affected area.

Treatment with Fluorouracil and Calcipotriene

Eligibility Criteria

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

You may qualify if:

• Ability to start treatment within 1 week of enrollment
• Patients must be age ≥18, not of childbearing potential, and have the presence of 4-15 clinically, visibly confirmed and discrete AKs in an at least 25 cm2 contiguous area on the head, neck, arm, or hand.
• Because no dosing or adverse event data are currently available on the use of fluorouracil in combination with calcipotriene in patients \<18 years of age, children are excluded from this study.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
• History of bilateral tubal ligation or another surgical sterilization procedure.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Known allergy to any component of the medications or vehicle.
• A wound or suspected skin cancer within 5cm of the area to be treated
• Immunosuppression, or use in the past month of medications that could impede skin assessment including but not limited to:
• Other topical medications with active ingredients including: topical steroids, topical calcineurin inhibitors, topical retinoids, imiquimod, diclofenac, etc.
• Artificial tanners Cytotoxic medications including: systemic fluorouracil, bleomycin, doxorubicin, cisplatin, etc.
• Ultraviolet therapy Oral nicotinamide Oral retinoids including: isotretinoin, acitretin
• History of hypercalcemia
• Clinical evidence of vitamin D toxicity
• Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
• History of bilateral tubal ligation or another surgical sterilization procedure.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Fluorouracil; calcipotriene

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mackenzie Wehner, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mackenzie Wehner, MD

CONTACT

713-792-6979; mwehner@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)