← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year (9 months on active, continuous treatment)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am older than 18 years.
Select...
I agree to use birth control during the study.
Select...
I am using birth control and have a negative pregnancy test.
Select...
I am willing to stop using certain skin creams, pain relievers, and my blood tests meet specific requirements.
Select...
I am fully active or can carry out light work.
Select...
I had early-stage skin cancer treatment and now have actinic keratosis.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction of actinic keratoses
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,679 Previous Clinical Trials
6,910,544 Total Patients Enrolled
1 Trials studying Non-melanoma Skin Cancer
173,229 Patients Enrolled for Non-melanoma Skin Cancer
University of Alabama at BirminghamLead Sponsor
1,565 Previous Clinical Trials
2,268,220 Total Patients Enrolled
4 Trials studying Non-melanoma Skin Cancer
48 Patients Enrolled for Non-melanoma Skin Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,508 Total Patients Enrolled

Media Library

Topical DFMO (Ornithine Decarboxylase (ODC) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04091022 — Phase 2
Non-melanoma Skin Cancer Research Study Groups: Placebo + Placebo, Diclofenac + DFMO
Non-melanoma Skin Cancer Clinical Trial 2023: Topical DFMO Highlights & Side Effects. Trial Name: NCT04091022 — Phase 2
Topical DFMO (Ornithine Decarboxylase (ODC) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04091022 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the combination of Diclofenac and DFMO tolerable for humans?

"The safety of the combination drug Diclofenac + DFMO has been assessed as a 2. This is because, while Phase 2 trials have documented data on its security, there are no studies yet that look into its efficacy."

Answered by AI

Is this research program currently recruiting participants?

"According to clinicaltrials.gov, this study is actively searching for participants and has been since January 18th 2021. Recently, the trial details have been updated as of November 14th 2022."

Answered by AI

What therapeutic purpose is Diclofenac + DFMO typically prescribed for?

"Diclofenac + DFMO is frequently prescribed to treat catarrh, but it can also be beneficial for photorefractive keratectomy, muscle strain and hand osteoarthritis."

Answered by AI

How many individuals are engaged in this clinical assessment?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, which was first posted on January 18th 2021, is actively enrolling participants. 138 individuals are needed from three distinct medical facilities."

Answered by AI

Have researchers conducted any other investigations on the combination of Diclofenac and DFMO?

"Currently, 28 trials are researching the efficacy of Diclofenac + DFMO. Out of these studies, 7 have entered Phase 3 of clinical testing. Although Mooresville, North carolina is home to many experiments on this combination therapy, it can be administered in 1,423 sites across the US."

Answered by AI
~21 spots leftby Nov 2024