Topical Diclofenac for Non-melanoma Skin Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires participants to stop using certain medications, including topical medications on areas of actinic damage and chronic NSAIDs or COX-2 inhibitors, except for low-dose aspirin. You can use acetaminophen for pain if needed.
What evidence supports the effectiveness of the drug diclofenac for treating non-melanoma skin cancer?
Is topical diclofenac safe for use in humans?
How does the drug diclofenac differ from other treatments for non-melanoma skin cancer?
Diclofenac is unique because it is applied topically (directly on the skin) and has shown effectiveness in treating actinic keratosis, a common precancerous skin condition. Unlike some other treatments, it can be used at home, which may be more convenient for patients who have difficulty visiting a clinic for therapies like photodynamic therapy.13459
What is the purpose of this trial?
This research study will test how well one topical medications work to prevent the development of non-melanoma skin cancers by reversing certain biomarkers in the skin. This study is also looking at the optimal dose of a medication in a small number of people. Biomarkers are molecules that are found in the body and inside of cells. Some biomarkers are associated with specific diseases such as skin cancer. In this study, one topical medication will be evaluated; diclofenac. Diclofenac and is approved by the Food and Drug Administration (FDA) for other uses. 24 patients will be enrolled in this study by University of Alabama at Birmingham.
Research Team
Craig Elmets, MD
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
This trial is for adults with good performance status, not undergoing other cancer treatments or major surgery within the last month. They must avoid certain medications and be willing to stop using topical products on damaged skin areas, except moisturizers and sunscreens. Women of childbearing age should use contraception and have a negative pregnancy test.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive topical diclofenac or placebo applied daily for 30 days to evaluate the effect on skin cancer biomarkers
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on biomarker reduction and actinic keratoses
Treatment Details
Interventions
- Diclofenac
- Placebo
Diclofenac is already approved in United States, European Union, Canada for the following indications:
- Ankylosing Spondylitis
- Aseptic Necrosis
- Back Pain
- Chronic Pain
- Frozen Shoulder
- Headache
- Migraine
- Muscle Pain
- Osteoarthritis
- Pain
- Period Pain
- Rheumatoid Arthritis
- Sciatica
- Spondyloarthritis
- Osteoarthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Migraine
- Pain
- Dysmenorrhea
- Osteoarthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Migraine
- Pain
- Dysmenorrhea
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
National Institutes of Health (NIH)
Collaborator