Fluorouracil + Calcipotriene for Actinic Keratosis

Recruiting in Palo Alto (17 mi)

Overseen byMackenzie Wehner, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults over 18 who are not pregnant, have 4-15 visible actinic keratoses on their head, neck, arm, or hand. They must be able to start treatment within a week and sign consent. Those with other cancers that don't affect the trial's safety can join. People with hypercalcemia, vitamin D toxicity, allergies to the meds, nearby skin cancer or wounds, or recent use of certain skin treatments cannot participate.

Inclusion Criteria

Ability to start treatment within 1 week of enrollment

Ability to understand and the willingness to sign a written informed consent document

I am over 18, cannot become pregnant, and have 4-15 visible AKs on my head, neck, arm, or hand.

+1 more

Exclusion Criteria

I have had high calcium levels in my blood.

Clinical evidence of vitamin D toxicity

Known allergy to any component of the medications or vehicle

+2 more

Participant Groups

The study tests two topical treatments for actinic keratosis: one group will apply fluorouracil alone while another will use fluorouracil combined with calcipotriene. The goal is to see which treatment is more effective in reducing sunspots on the skin.

2Treatment groups

Experimental Treatment

Group I: Treatment with Fluorouracil and CalcipotrieneExperimental Treatment1 Intervention

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

Group II: Treatment with FluorouracilExperimental Treatment1 Intervention

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