Solaraze + Vaniqa for Skin Cancer

No longer recruiting at 2 trial locations

Overseen By Leslie Roop

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

Must not be taking: NSAIDs, Corticosteroids, Chemotherapy, Retinoids

Disqualifiers: Invasive cancer, Transplant, Cirrhosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two topical treatments, diclofenac and DFMO, to determine if they can prevent the recurrence of non-melanoma skin cancers, such as basal or squamous cell skin cancer. Participants will apply either the active treatments or a placebo—a harmless, inactive cream—on their forearms. The goal is to assess whether these creams can reduce skin cancer risk or visible signs on the skin. This trial suits individuals who have previously had basal or squamous cell skin cancer treated and currently have rough, scaly patches called actinic keratosis on areas like their arms or face. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. The trial requires you to avoid using topical medications on treatment areas and chronic use of NSAIDs (non-steroidal anti-inflammatory drugs) or COX-2 inhibitors. If you're using these, you might need to stop for the duration of the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both topical DFMO and topical diclofenac show promise for skin issues. Several studies have tested topical DFMO, demonstrating some success in reducing actinic keratosis (AK), which are rough skin patches that can potentially become cancerous. These studies reported no major safety concerns.

The FDA has already approved topical diclofenac for treating actinic keratosis. It is generally safe when used as directed, but users should avoid sun exposure on treated areas, as the gel can increase skin sensitivity.

In summary, both treatments have been studied and appear safe for skin use. However, like any treatment, they may cause side effects. Discuss any concerns with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of topical DFMO and topical diclofenac for treating skin cancer because it offers a unique dual approach. Unlike traditional treatments, which often rely on surgery or radiation, this combination targets cancer cells directly on the skin. DFMO works by inhibiting an enzyme essential for cancer cell growth, while diclofenac reduces inflammation and may enhance cancer cell death. This topical method could potentially provide a less invasive and more convenient option for patients, aiming to reduce side effects associated with systemic treatments.

What evidence suggests that this trial's treatments could be effective for non melanoma skin cancer?

Research has shown that topical DFMO cream can reduce actinic keratosis (AK) spots on the skin by 56% to 90%. This trial will test the combination of topical DFMO and topical diclofenac, which is already approved for treating actinic keratosis. Previous studies found topical diclofenac very effective, with up to 58% of patients seeing all their spots disappear. Participants in this trial will apply both treatments to the skin to reduce or clear these pre-cancerous spots, potentially lowering the risk of developing skin cancer. ^{1 3 4 5 6}

Who Is on the Research Team?

Craug Elmets, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to participate for the full duration of the study

I am older than 18 years.

I agree to use birth control during the study.

Exclusion Criteria

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

I am using topical steroids on my forearms.

I haven't had skin treatments like peels or laser on my forearms in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical diclofenac and topical DFMO or placebo for 9 months

9 months

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Topical DFMO
• Topical Diclofenac

Trial Overview

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.

How Is the Trial Designed?

Group I: Diclofenac + DFMO Active Control 1 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 + Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Solaraze gel, which contains 3% diclofenac, has been used since 2001 as a topical treatment for actinic keratoses and is commonly utilized in dermatology.

While undesirable effects from Solaraze gel are considered rare, they can include skin reactions such as pruritus, paresthesia, and contact dermatitis, with recent reports highlighting cases of contact dermatitis linked to diclofenac and other allergens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoallergic contact dermatitis from topical diclofenac in Solaraze gel. Kowalzick, L., Ziegler, H.[2013]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39614759/

Evaluating Difluoromethylornithine Safety and Efficacy for ...

Topical DFMO shows modest efficacy in reducing the number of actinic keratosis (AK), as indicated in 4 studies representing 38.12% (154/404) ...

2.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/12034754241302818?int.sj-abstract.similar-articles.3

Evaluating Difluoromethylornithine Safety and Efficacy for Non- ...

Topical DFMO shows modest efficacy in reducing the number of actinic keratosis (AK), as indicated in 4 studies representing 38.12% (154/404) of patients.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4778979/

Phase IIB Randomized Study of Topical ...

The reduction in number of actinic keratoses ranges between 56-90% with this treatment (10, 11). The effects of treatment continue after ...

4.

aacrjournals.org

aacrjournals.org/clincancerres/article/8/1/149/288980/Modulation-of-Biologic-Endpoints-by-Topical

Modulation of Biologic Endpoints by Topical ... - AACR Journals

We reported previously results of a randomized, placebo-controlled trial of topical DFMO in 48 participants with AK. In this study there was a significant ...

5.

researchgate.net

researchgate.net/publication/386288826_Evaluating_Difluoromethylornithine_Safety_and_Efficacy_for_Non-Melanoma_Skin_Cancer_Chemoprevention_A_Systematic_Review

Evaluating Difluoromethylornithine Safety and Efficacy for ...

Topical DFMO shows modest efficacy in reducing the number of actinic keratosis (AK), as indicated in 4 studies representing 38.12% (154/404) ...

6.

journals.sagepub.com

journals.sagepub.com/doi/abs/10.1177/12034754241302818

Evaluating Difluoromethylornithine Safety and Efficacy for ...

Topical DFMO shows modest efficacy in reducing the number of actinic keratosis (AK), as indicated in 4 studies representing 38.12% (154/404) of patients.