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Skin cancer survivors test cream combo to stop new tumors

NCT ID NCT04091022

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a combination of two FDA-approved creams (diclofenac and DFMO) can prevent new non-melanoma skin cancers in people who have already had them. 64 participants applied the creams or a placebo to their arms for 9 months. The goal was to see if the treatment reduced the number of precancerous spots and new skin cancers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
topical diclofenac 3% cream and topical eflornithine (DFMO) 13.9% cream
What this could lead to
If successful, this combination cream could offer a new way to prevent non-melanoma skin cancers from forming in people who have already had them.
What could go wrong
This is a small, early-phase trial (64 participants) testing a combination of two existing drugs for a new purpose. The results may not be strong enough to change practice, and skin irritation from the creams is possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

64 people

The number who actually took part.

Started

Jan 2021

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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: * 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. Exclusion Criteria 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 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Birmingham VA Medical Center

    Birmingham, Alabama, 35233, United States

  • UAB Dermatology

    Birmingham, Alabama, 35233, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.