Solaraze + Vaniqa for Skin Cancer

Recruiting at 2 trial locations

Overseen By Leslie Roop

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

138 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single institution, randomized, placebo-controlled, double-blind phase IIB trial of 1) topical diclofenac and topical DFMO, or 2) placebo in participants with a history of non melanoma skin cancer/ keratinocytic cancers.

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.

What data supports the effectiveness of the drug Solaraze + Vaniqa for skin cancer?

Research shows that diclofenac 3% gel has been effective in treating actinic keratosis (a skin condition that can lead to cancer) and may help prevent its progression. However, studies on the combination of diclofenac and DFMO for preventing skin cancer have not shown enhanced effectiveness compared to using diclofenac alone. ^{1 2 3 4 5}

Is the combination of Solaraze and Vaniqa safe for treating skin conditions?

The combination of Solaraze (diclofenac) and Vaniqa (DFMO) has been studied for skin conditions, showing that both can cause local skin inflammation. Diclofenac, in particular, has been associated with more adverse events, including severe local reactions in some patients, and one study noted a high death rate in mice treated with diclofenac. Overall, while generally well tolerated, there are risks of local skin reactions, and some individuals may be more susceptible to these effects. ^{1 2 4 6 7}

How does the drug Solaraze + Vaniqa for skin cancer differ from other treatments?

The combination of Solaraze (diclofenac) and Vaniqa (DFMO) is unique because it uses two topical agents that have shown potential in preventing nonmelanoma skin cancers by targeting sun-damaged skin. This approach is different from standard treatments as it combines anti-inflammatory and chemopreventive properties, although the study found that adding DFMO did not enhance the activity of diclofenac alone. ^{1 7 8 9 10}

Research Team

Craug Elmets, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Phase IIB Randomized Study of Topical Difluoromethylornithine and Topical Diclofenac on Sun-Damaged Skin of the Forearm. [2018]

2. Denmark pubmed.ncbi.nlm.nih.gov

High death rate in mice treated topically with diclofenac. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Topical treatment with diclofenac, calcipotriol (vitamin-D3 analog) and difluoromethylornithine (DFMO) does not prevent nonmelanoma skin cancer in mice. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Does progression from actinic keratosis and Bowen's disease end with treatment: diclofenac 3% gel, an old drug in a new environment? [2013]

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

Long-term Follow up of Diclofenac Sodium 3% in 2.5% Hyaluronic Acid Gel for Actinic Keratosis: One-year Evaluation. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Genetically determined susceptibility to COX-2 inhibitors: a report of exaggerated responders to diclofenac 3% gel in the treatment of actinic keratoses. [2013]

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

A single-arm, open-label efficacy and tolerability study of diclofenac sodium 3% gel for the treatment of actinic keratosis of the upper and lower lip. [2013]

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

Diclofenac sodium 3% gel for the management of actinic keratosis: 10+ years of cumulative evidence of efficacy and safety. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Photoallergic contact dermatitis from topical diclofenac in Solaraze gel. [2013]

10. France pubmed.ncbi.nlm.nih.gov

3% diclofenac in 2.5% hyaluronic acid (Solaraze) does not induce photosensitivity or phototoxicity alone or in combination with sunscreens. [2013]