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Ornithine Decarboxylase (ODC) Inhibitor

Solaraze + Vaniqa for Skin Cancer

Phase 2

Waitlist Available

Led By Craug 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

Age >18 years

All females of childbearing potential and all men capable of fathering a child must agree to use adequate contraception for the duration of study participation

Must not have

Cryotherapy to intended treatment area (forearms) within the preceding 3 months

Current use of topical steroids to intended treatment area (forearms)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year (9 months on active, continuous treatment)

Summary

This trial is testing whether a topical combination of drugs can prevent skin cancer in people who have had skin cancer in the past.

Who is the study for?

Adults over 18 with a history of non-melanoma skin cancer and at least one actinic keratosis can join. They must not be pregnant, agree to use contraception, avoid certain medications like NSAIDs, and have no major surgeries or cancer treatments within the last month. People with invasive cancers, serious illnesses, or recent cryotherapy on their forearms are excluded.

What is being tested?

The trial is testing two topical treatments: Diclofenac (Solaraze) and DFMO (Vaniqa), against a placebo in people who've had skin cancer. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment versus placebo.

What are the potential side effects?

Possible side effects may include local skin reactions such as redness, itching or rash where the medication is applied. Since these are topical treatments, systemic side effects are less common but could still occur.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I agree to use birth control during the study.

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

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I am willing to stop using certain skin creams, pain relievers, and my blood tests meet specific requirements.

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I am fully active or can carry out light work.

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I had early-stage skin cancer treatment and now have actinic keratosis.

Exclusion Criteria

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

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I have not had cryotherapy on my forearms in the last 3 months.

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I am using topical steroids on my forearms.

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I am not using certain skin or cancer treatments, and I am not pregnant or breastfeeding.

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I do not have any serious illnesses that are not under control.

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I haven't had major surgery or cancer treatment in the last 4 weeks.

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I take more than 100 mg of aspirin daily.

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I regularly take NSAIDs or COX-2 inhibitors.

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I have been on steroids for more than 2 weeks.

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A close family member has Ornithine Transcarbamylase Deficiency.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year (9 months on active, continuous treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year (9 months on active, continuous treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year (9 months on active, continuous treatment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Reduction of actinic keratoses

Secondary study objectives

Biomarker assessment

Biomarker assessment of NMSC

Safety assessment

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Diclofenac + DFMOActive Control1 Intervention

Participants in this arm will apply topical diclofenac to bilateral forearms once per day and topical DFMO to bilateral forearms once per day.

Group II: Placebo + PlaceboPlacebo Group1 Intervention

Participants in this arm will apply placebo for topical diclofenac to bilateral forearms once per day and placebo for topical DFMO to bilateral forearms once per day.

0 / 15Eligibility criteria met