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Pilot Study for Actinic Keratoses Treatment

This study is comparing two skin treatments for multiple actinic keratoses (rough, scaly patches on the skin caused by sun exposure). You would receive either fluorouracil (a chemotherapy cream) alone, or fluorouracil combined with calcipotriene (a form of vitamin D). Researchers want to see if combining these medications is safe and effective. They also want to understand how many people are willing to join this type of study to help plan future research. To be eligible, you must be at least 18 years old, not able to become pregnant, and have 4-15 visible actinic keratoses on your head, neck, arm, or hand. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is an interventional pilot study, meaning participants will receive a specific treatment. It aims to enroll 30 participants to compare two different topical treatments.
What's involved
You would apply your assigned medication twice daily for either 2-3 weeks (fluorouracil alone) or 4 days (fluorouracil/calcipotriene). You must be able to start treatment within one week of joining.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored throughout the study, which is expected to last an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06851507

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

Recruiting
PHASE3Ages 18+InterventionalSupportive care
M.D. Anderson Cancer Center
~30 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Fluorouracil 5-FUFluorouracil/Calcipotriene

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year.

Conditions

Multiple Actinic Keratoses

Explore related trials

Actinic Keratosis

NCT06851507

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas M. D. Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mackenzie Wehner, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Mackenzie Wehner, MD
[email protected]
713-792-6979
Email the study team

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Eligibility criteria

Inclusion

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.
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.
The effects of topical fluorouracil and/or fluorouracil plus calcipotriene on the developing human fetus are unknown. From the topical fluorouracil package insert: "One birth defect (cleft lip and palate) has been reported in the newborn of a patient using EFUDEX as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when EFUDEX was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil."11 For this reason, we are excluding women of child-bearing potential. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:

Exclusion

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:
History of hypercalcemia
Clinical evidence of vitamin D toxicity
The effects of topical fluorouracil and/or fluorouracil plus calcipotriene on the developing human fetus are unknown. From the topical fluorouracil package insert: "One birth defect (cleft lip and palate) has been reported in the newborn of a patient using EFUDEX as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when EFUDEX was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil."11 For this reason, we are excluding women of child-bearing potential. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:

What this trial measures

  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year.

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