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

Conditions

• Multiple Actinic Keratoses

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Oct 6, 2025

Status verified

Apr 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Treatment with Fluorouracil and Calcipotriene
  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
• Experimental: Treatment with Fluorouracil
  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

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

• Mackenzie Wehner, MD
  713-792-6979
  [email protected]

Locations (1)

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