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

NCT04091022 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: 300004144R01CA193885
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Non-melanoma Skin Cancer

Keywords

topical chemoprevention

Outcome Measures

Primary Outcomes (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.

  one year (9 months on active, continuous treatment)

Secondary Outcomes (3)

• Safety assessment

  one year (9 months on active, continuous treatment)

• Biomarker assessment

  one year (9 months on active, continuous treatment)

• Biomarker assessment of NMSC

  one year (9 months on active, continuous treatment)

Study Arms (2)

Diclofenac + DFMO

ACTIVE COMPARATOR

Participants in this arm will apply topical diclofenac to bilateral forearms once per day and topical DFMO to bilateral forearms once per day.

Drug: Solaraze and Vaniqa

Placebo + Placebo

PLACEBO COMPARATOR

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.

Drug: Solaraze and Vaniqa

Interventions

Solaraze and Vaniqa DRUG

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

Also known as: Solaraze-topical diclofenac 3% and Vaniqa-topical eflornithine hydrochloride Cream, 13.9%

Diclofenac + DFMO; Placebo + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

Location

UAB Dermatology

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Interventions

Diclofenac; Eflornithine

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Study Officials

• Craug Elmets, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial will be double-blinded. The clinical team and patient will remain blinded to the randomization. All study drug will be blinded except to the pharmacists. Records will be kept to document receipt, distribution and disposition of the drugs. Unblinding will only be done at the end of the study or as medically indicated with consent of the study PI and the biostatistician, after consulting the NIH Project Officer.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized, placebo-controlled, double-blind

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 16, 2019
• Study Start: January 18, 2021
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (2)