Fluorouracil + Calcipotriene for Actinic Keratosis

Overseen By Mackenzie Wehner, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Topical steroids, Oral retinoids

Disqualifiers: Immunosuppression, Hypercalcemia, Skin cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2-3 weeks

30 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications that could affect skin assessment, such as topical steroids, retinoids, and some oral medications like nicotinamide. If you're using any of these, you may need to stop them before participating.

Is the combination of Fluorouracil and Calcipotriene safe for treating actinic keratosis?

Fluorouracil cream, used alone for actinic keratosis, is generally safe with most side effects being mild to moderate skin irritation. No unexpected adverse events were reported in studies, and the treatment is considered safe for use in humans. ^{1 2 3 4 5}

How is the drug Fluorouracil + Calcipotriene unique for treating actinic keratosis?

Fluorouracil combined with Calcipotriene for actinic keratosis is unique because it potentially offers a synergistic effect, where Calcipotriene (a vitamin D analog) may enhance the efficacy of Fluorouracil while possibly reducing its skin irritation side effects, which are common with Fluorouracil alone. ^{1 4 6 7 8}

What data supports the effectiveness of the drug combination of Fluorouracil and Calcipotriene for treating actinic keratosis?

Research shows that Fluorouracil is effective in reducing actinic keratosis lesions, with studies demonstrating significant lesion reduction and complete clearance in some cases. Although Calcipotriene is not specifically mentioned in these studies, the combination with Fluorouracil may enhance treatment effectiveness by potentially reducing skin irritation while maintaining efficacy. ^{1 4 6 8 9}

Who Is on the Research Team?

Mackenzie Wehner, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive topical 5-FU twice daily for 2-3 weeks

2-3 weeks

Standard-of-care clinical dermatology visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Calcipotriene
• Fluorouracil

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment with Fluorouracil and Calcipotriene Experimental Treatment 1 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 Fluorouracil Experimental Treatment 1 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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A 1-week treatment with microsponge-based fluorouracil cream 0.5% significantly reduced actinic keratoses (AK) lesions compared to a vehicle control, demonstrating its efficacy (P<.001) in a study involving 356 participants.

The treatment was well-tolerated, with no serious adverse events reported, and only mild to moderate skin irritations experienced, indicating it is a safe option for patients with AKs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-week treatment with once-daily fluorouracil cream 0.5% in participants with actinic keratoses. Menter, A., Vamvakias, G., Jorizzo, J.[2013]

In a study involving 277 participants over 18 months, fluorouracil cream 0.5% was found to be safe and well-tolerated, with only 4 participants (7.4%) experiencing mild treatment-related adverse events.

The cream significantly reduced actinic keratosis (AK) lesions, achieving clearance rates of 39.8% on the face/anterior scalp and 79.1% on the lips after the first treatment cycle, with continued effectiveness observed during a second treatment cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorouracil cream 0.5% for actinic keratoses on multiple body sites: an 18-month open-label study. Stough, D., Bucko, AD., Vamvakias, G., et al.[2013]

A study involving 177 patients demonstrated that a microsphere-based formulation of 0.5% fluorouracil cream is effective in treating actinic keratosis (AK), with significant improvements in lesion counts and clearance compared to a vehicle control.

The treatment was found to be safe, with most patients experiencing only mild to moderate facial irritation, and efficacy increased with longer treatment durations of 1, 2, or 4 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective treatment of actinic keratosis with 0.5% fluorouracil cream for 1, 2, or 4 weeks. Weiss, J., Menter, A., Hevia, O., et al.[2013]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

One-week treatment with once-daily fluorouracil cream 0.5% in participants with actinic keratoses. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Fluorouracil cream 0.5% for actinic keratoses on multiple body sites: an 18-month open-label study. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Topical treatment of actinic keratosis with fluorouracil: is irritation associated with efficacy? [2013]

4. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of low-dose 5-fluorouracil/salicylic acid in actinic keratoses in relation to treatment duration. [2015]

5. England pubmed.ncbi.nlm.nih.gov

A prospective randomized exploratory study comparing the efficacy of once-daily topical 0.5% 5-fluorouracil in combination with 10.0% salicylic acid (5-FU/SA) vs. cryosurgery for the treatment of hyperkeratotic actinic keratosis. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Effective treatment of actinic keratosis with 0.5% fluorouracil cream for 1, 2, or 4 weeks. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Fluorouracil cream 0.5% for the treatment of actinic keratoses on the face and anterior scalp: interim results of an 18-month open-label study. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Actinic Keratoses: A Prospective Pilot Study on a Novel Formulation of 4% 5-Fluorouracil Cream and a Review of Other Current Topical Treatment Options. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Fluorouracil 5% and 0.5% creams for the treatment of actinic keratosis: equivalent efficacy with a lower concentration and more convenient dosing schedule. [2013]