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Nonsteroidal Anti-inflammatory Drug

Topical Diclofenac for Non-melanoma Skin Cancer

Phase 2

Waitlist Available

Led By Craig Elmets, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0-1

Willing to abstain from chronic NSAID and COX-2 inhibitor use (other than cardioprotective doses of aspirin < 100 mg po QD) for the duration of the study. For routine analgesia, subjects may take acetaminophen as necessary.

Must not have

Major surgery for any indication, cytotoxic chemotherapy, anti-cancer treatment of any type other than for a stage 0-2 non-melanoma skin cancer, hormonal therapy for cancer prevention, radiation therapy, or specified topical medications within 4 weeks prior to randomization

Nasally inhaled corticosteroids (except mometasone - Nasonex), aspirin (>100 mg/day), NSAIDs (other than aspirin < 100mg/day) or COX-2 inhibitors > 3 times/week for more than a two week period, and topical steroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Summary

This trial will study the effects of a topical medication, diclofenac, on the prevention of non-melanoma skin cancers. The study will also assess the optimal dose of the medication. Diclofenac is already approved by the FDA for other uses. 24 patients will be enrolled in the study.

Who is the study for?

This trial is for adults with good performance status, not undergoing other cancer treatments or major surgery within the last month. They must avoid certain medications and be willing to stop using topical products on damaged skin areas, except moisturizers and sunscreens. Women of childbearing age should use contraception and have a negative pregnancy test.

What is being tested?

The study tests if diclofenac cream can prevent non-melanoma skin cancers by reversing biomarkers in the skin. It's a small-scale trial at University of Alabama involving 24 patients to find the best dose. Diclofenac is FDA-approved for other uses but not yet for this one.

What are the potential side effects?

Potential side effects may include local skin reactions like redness, itching or rash where the cream is applied. Since diclofenac is an NSAID, it could also cause systemic effects such as stomach upset or rarely allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I agree not to take certain pain relievers, except for low-dose aspirin, during the study.

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My blood, liver, and kidney tests are within normal ranges.

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I am using birth control and have a negative pregnancy test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery, chemotherapy, or other cancer treatments except for early-stage skin cancer in the last 4 weeks.

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I use certain nasal sprays, aspirin over 100mg/day, NSAIDs, or COX-2 inhibitors more than 3 times a week.

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I have not used corticosteroids for more than 2 weeks in the last 6 months.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Optimal Dosing of topical diclofenac and topical DFMO for the reduction of actinic keratoses

Optimal Dosing of topical diclofenac and topical DFMO for the reduction of non melanoma skin cancer biomarkers

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: diclofenac once dailyActive Control1 Intervention

Topical diclofenac, will will be applied onto the skin of one arm, every day for 30 days. Enough medication will be used to cover an area of approximately 4 square inches( a 2 inch by 2 inch square). The medications will come in a tube. The medications will be applied to the same sun exposed site on the arm every day. The research team will provide instructions for the correct application of the treatment.

Group II: placeboPlacebo Group1 Intervention

The topical medication will will be applied onto the skin of one arm, once daily for 30 days. Enough placebo will be used to cover an area of approximately 4 square inches( a 2 inch by 2 inch square). The placebo will come in a tube. The placebo will be applied to the same sun exposed site on the arm every day. The research team will provide instructions for the correct application of the treatment.

0 / 8Eligibility criteria met