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Non-melanoma Skin CancerPhase 2NCT04091022

Topical Diclofenac and Topical DFMO Chemoprevention Trial in Subjects With a History of Skin Cancer

A Phase 2 study testing Solaraze and Vaniqa in people with Non-melanoma Skin Cancer, run by University of Alabama at Birmingham at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-melanoma Skin Cancer
What is being tested?
Solaraze and Vaniqa
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
2 sitesUnited States
Study dates
18 Jan 2021to 11 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previous treatment for basal or squamous cell skin cancer stage 0-2 and current evidence of at least actinic keratosis on the upper extremities (upper arms, forearms and hands), neck, face or scalp.
  • >18 years of age
  • Ability to understand and willingness to sign a written informed consent document
  • ECOG performance status 0-1
  • Willing and able to participate for the full duration of the study
  • Willing to abstain from:
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  • The application of topical medications including prescription and over the counter preparations (e.g., Topical preparations containing corticosteroids or vitamin A derivatives) to intended treatment areas for the duration of the study. Use of moisturizers/emollients and sunscreens on these areas is allowed.
  • Chronic (defined as > 3 times/week for more than 2 consecutive weeks/year) NSAID and COX-2 inhibitor use (other than cardioprotective doses of aspirin < 100 mg po QD) for the duration of the study
  • Normal organ and marrow function defined as laboratory values falling within the specified ranges for the following tests (performed within 365 days of registration)
  • Hematologic
  • WBC >3,000/ul
  • Hemoglobin > lower limit of normal
  • Platelet count > 100,000/ul
  • Hepatic
  • Total bilirubin < 1.5 X ULN
  • AST (SGOT) < 1.5 X ULN
  • ALT (SPGT) < 1.5 X ULN Renal
  • Serum creatinine < 1.5 X ULN BUN < 1.5 X ULN
  • Females of childbearing potential must:
  • Have been using adequate contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) since their last menses
  • Have a documented negative urine pregnancy test prior to the first dose of study medication. (Females are not considered to be of childbearing potential if they are at least 1 year post-menopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy)
  • The effects of DFMO and diclofenac on the developing fetus are unknown. Therefore, all females of childbearing potential and all men capable of fathering a child must agree to use adequate contraception (abstinence, IUD, birth control pills, or spermicidal gel with diaphragm or condom) for the duration of study participation.

Who cannot join

  • Any of the following will render a participant ineligible to participate in this study:
  • Aspirin >100 mg/day
  • Chronic (> 3 times/week for more than a two week period) use of NSAIDs or COX-2 inhibitors
  • Current use of topical steroids to intended treatment area (forearms)
  • Cryotherapy to intended treatment area (forearms) within the preceding 3 months
  • Use of oral or intravenous corticosteroids for more than 2 consecutive weeks
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  • Any of the following in the 4 weeks prior to randomization:
  • Major surgery for any indication
  • Cytotoxic chemotherapy for any indication (including methotrexate for arthritis)
  • Anti-cancer treatment of any type other than for a stage 0-2 non-melanoma skin cancer
  • Hormonal therapy for cancer prevention ((treatment with finasteride/dutasteride for BPH does not render a participant ineligible.)
  • Radiation therapy
  • Any of the following in the 6 month prior to randomization to the intended treatment area (forearms):
  • Topical medications for the treatment of actinic keratosis or skin cancer (etretinate, 5-FU, imiquimod, ingenol)
  • Laser resurfacing, dermabrasion, chemical peel and/or electrodissection ± curettage
  • Any family history of Ornithine diaminotransferase deficiency in a first degree relative
  • Any personal history of:
  • Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for >5 years and have not required treatment in the past 5 years may be eligible if a study chair or principal investigator believes there is little to no risk of recurrence.
  • Solid organ or bone marrow transplant
  • Biopsy proven hepatic cirrhosis
  • Keloid formation
  • Photosensitivity disorder
  • Hypersensitivity or adverse reactions to nonsteroidal anti-inflammatory agents
  • Oral DFMO for > 1 month on a prior study
  • Any disease that predisposes to NMSC
  • An immunodeficiency disorder or the use of an immunosuppressive drug
  • Concurrent use of the following medications or treatments:
  • Systemic therapy with psoralens, immunotherapy, or retinoids.
  • Cytotoxic chemotherapy for any reason (including methotrexate for arthritis)
  • Topical or systemic immunosuppressive therapy
  • Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should notify her study physician immediately.
  • Uncontrolled concurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled symptomatic cardiac arrhythmia, psychiatric illness/social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion might preclude study participation.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Birmingham VA Medical Center

    Birmingham, Alabama, 35233

  • UAB Dermatology

    Birmingham, Alabama, 35233

Other trials in United States

About this study

Official title: A Randomized, Placebo-controlled, Double-blind, Phase II Chemoprevention Clinical Trial of Topical Diclofenac and DFMO in Subjects With a History of Skin Cancer

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.

Read the detailed description

There will be two groups to the study. Individuals, aged 18 years or older, who have extensive actinic damage, at least 8 AKs and a history of at least one non-melanoma skin cancer, but are in otherwise general good health, will be given topical diclofenac and topical DFMO. They will be compared to individuals, aged 18 years or older, who have extensive actinic damage, but are in otherwise general good health, will be given placebo. All participants must be at increased risk of non-melanoma skin cancer as evidenced by a history of prior squamous or basal cell skin cancer, ongoing or history of actinic keratoses, and the presence, at baseline, of at least eight actinic keratoses on the face, neck, scalp and arms. Subjects will be randomized to:

  1. topical diclofenac once daily and topical DFMO once daily
  2. placebo for the topical diclofenac once daily and placebo for the topical DFMO once daily
Being tested
Solaraze and Vaniqa
Keywords
topical chemoprevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solaraze and VaniqaDrug

    Also called Solaraze-topical diclofenac 3% and Vaniqa-topical eflornithine hydrochloride Cream, 13.9%

    Solaraze-topical diclofenac 3% and Vaniqa-topical eflornithine hydrochloride Cream, 13.9% applied to bilateral arms for a period of 9 months

Study groups in NCT04091022
Study groupRoleWhat they receive
Diclofenac + DFMOActive comparatorParticipants in this arm will apply topical diclofenac to bilateral forearms once per day and topical DFMO to bilateral forearms once per day.
Receives: Drug: Solaraze and Vaniqa
Placebo + PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Solaraze and Vaniqa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of actinic keratoses

    The purpose of the study is to determine whether participants randomized to a combination of two FDA approved topical medications topical diclofenac and topical DFMO have a significant change in incidence of (≥ 50% change, p ≤ 0.05) non-melanoma skin cancers (NMSC) than participants randomized to placebo as assessed by clinical and histopathological evaluation.

    Measured: one year (9 months on active, continuous treatment)

Secondary outcomes (3)

  1. Safety assessment

    Determination of safety of the combination of topical diclofenac and topical DFMO as compared to placebo using the NCI- Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: one year (9 months on active, continuous treatment)

  2. Biomarker assessment

    To assess the effect of topical diclofenac and topical DFMO on the following biomarkers in biopsied non-sun exposed skin, skin tissue that has chronic sun damage, and in actinic keratosis skin lesions at 0 and 9 months:

    mRNA expression of Sonic Hedgehog, Hip1, Ptch1, Gli1, Gli2, Gli3, and p53, Prostaglandin E2, Proliferation indices (PCNA, cyclin D1), Apoptosis markers (Tunel staining, Bcl-2, caspase-3), Polyamine concentrations (putrescine, spermidine, spermine)

    Measured: one year (9 months on active, continuous treatment)

  3. Biomarker assessment of NMSC

    Effect of topical diclofenac and topical DFMO on biomarkers of squamous cell skin cancer and basal cell skin cancer which include mRNA expression of p53,proliferation indices (PCNA, cyclin D1),apoptosis markers (Tunel staining, Bcl-2, caspase-3), andmarkers of epithelial adhesion (E-cadherin)

    Measured: one year (9 months on active, continuous treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2019
  2. Study start18 Jan 2021
  3. Primary completion11 Dec 2025
  4. Study completion11 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, placebo-controlled, double-blind
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04091022
Sponsor's protocol ID
300004144
Other IDs
R01CA193885
Status last verified
Dec 2025
First submitted
4 Sep 2019
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Solaraze and Vaniqa in people with Non-melanoma Skin Cancer, run by University of Alabama at Birmingham at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of actinic keratoses (time frame: one year (9 months on active, continuous treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04091022.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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