NCT06851507

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives: The primary objective of this pilot trial is feasibility, specifically measured by percent of patients approached and screened who enroll in the study. The prior trial on these medications reported a 75% enrollment rate (132 enrolled of 175 patients screened), though other trials of AK treatments have had lower enrollment rates (e.g., 53%9). To accurately plan a multi-site trial and apply for funding, an enrollment rate from the pilot trial will be critical. We will consider 50% enrollment rate a success, based on the lowest enrollment rates we found in the AK trial literature. Secondary Objectives: A. The proportion of participants who complete the treatment course, B. The change in AK count from baseline C. The proportion of participants who have clearance of \>75% of AKs D. Differences in adverse event reporting, in particular redness, scaling, burning, pain, and itch, E. Comparison of counts of AK lesions by dermatologists in person to counts of AK lesions by dermatologists using standardized digital photography. F. Change in MASCK metric G. Patient satisfaction (AK-EPQ) H. Change in health related QoL (AK-QoL) I. Patient adherence (ability to complete entire recommended course)

Conditions

• Multiple Actinic Keratoses

Interventions

Type	Name	Description
DRUG	Fluorouracil 5-FU	Participants in the fluorouracil arm will apply fluorouracil twice daily for 2-3 weeks (depending on body area).
DRUG	Fluorouracil/Calcipotriene	Participants in the fluorouracil/calcipotriene will apply fluorouracil/calcipotriene twice daily for 4 days to the affected area.

Timeline

• Start date: 2025-10-06
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2025-02-28
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States