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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-melanoma Skin Cancer

In brief

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.

Key facts

Study ID

NCT04091022

Run by

University of Alabama at Birmingham

People needed

64

Starts

2021-01-18

Expected to finish

2025-12-11

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Birmingham VA Medical Center — Birmingham, Alabama, United States
• UAB Dermatology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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