Non-melanoma Skin CancerPhase 2NCT02636569
Topical Chemoprevention of Skin Cancer Biomarkers
A Phase 2 study testing topical diclofenac daily in people with Non-melanoma Skin Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. 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?
- topical diclofenac daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2017to 31 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
- o 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
- Greater than 4 weeks from:
- Prior major surgery for any indication Prior chemotherapy, hormonal therapy or radiation therapy for cancer o 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 areas of actinic damage 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. For routine analgesia, subjects may take acetaminophen as necessary.
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- Normal organ and marrow function defined as laboratory values falling within the specified ranges for the following tests (performed within 14 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 serum pregnancy test within 14 days 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.
- o The effects of topical DFMO + topical diclofenac on the developing fetus are unknown. Therefore all females of childbearing potential 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
- o Within 6 months prior to randomization: Use of oral or intravenous corticosteroids for more than 2 consecutive weeks Use of inhaled corticosteroids for more than 4 consecutive weeks
- o Any of the following in the 4 weeks (or as indicated) 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 (including tamoxifen) Note: treatment with finasteride/dutasteride for BPH does not render a participant ineligible.
- Radiation therapy Topical medications for the treatment of actinic keratosis or skin cancer (retin A, 5-FU, imiquimod) in the 6 months prior to randomization.
- Laser resurfacing, dermabrasion, cryotherapy, chemical peel and electrodissection ± curettage in the 6 months prior to randomization.
- Nasally inhaled corticosteroids (except mometasone - Nasonex) Aspirin (>100 mg/day) - Note: cardioprotective doses (< 100mg/day) are acceptable.
- NSAIDs (other than aspirin < 100mg/day) or COX-2 inhibitors > 3 times/week for more than a two week period Topical steroids
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- o Any personal history of: Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more and have not required treatment in the past 5 years may be eligible if the principal investigator believes there is little to no risk of recurrence.
- Solid organ or bone marrow transplant Keloid formation Photosensitivity disorder Hypersensitivity or adverse reactions to nonsteroidal anti-inflammatory agents or to DFMO Any disease that predisposes to NMSC An immunodeficiency disorder or the use of an immunosuppressive drug Any skin disease that would interfere with interpretation of results
- Any family history of Ornithine diaminotransferase deficiency in a first degree relative
- Concurrent use of the following medications or treatments Anticoagulants including warfarin and heparin Other NSAIDs (other than aspirin <100 mg/day) on a daily basis Topical chemotherapy, cryotherapy, radiotherapy or any other skin lesion treatment to areas of skin being followed in this study Systemic therapy with psoralens, immunotherapy, retinoids, or radiation therapy Cytotoxic chemotherapy for any reason (including methotrexate for arthritis) Laser resurfacing, dermabrasion or chemical peels 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 the study physician immediately.
- Uncontrolled concurrent illness including ongoing or active infection, 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
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Whitaker Clinic
Birmingham, Alabama, 35233
About this study
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.
Read the detailed description
Men and women (≥ 18 yo)who have been seen as patients in the Dermatology Clinic at the University of Alabama at Birmingham with a history of basal cell or squamous cell carcinoma of the skin and at least 8 actinic keratoses on the upper extremities are potentially eligible for study participation.
We propose to examine one topical medication which is already FDA approved,with a placebo comparator. The purpose of the study is to see if diclofenac applied daily will affect levels of specific biomarkers in the skin that are associated with risk of developing skin cancer. We hope to see these levels decrease with once daily use of this medication. Results from this study will help guide us in a second study where we will look at longer term use of these medications and how they are associated with changes in skin biomarkers that are related to skin cancer. The second longer study will use the dose (once or twice daily topical application of diclofenac and DMFO) that resulted in a decrease in biomarkers, as discovered in this currently proposed study.
- Conditions
- Non-melanoma Skin Cancer
- Being tested
- topical diclofenac daily, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical diclofenac dailyDrug
Also called topical diclofenac
Topical diclofenac will be applied daily for 30 days. Each subject will be seen for a screening visit as well as a baseline visit and a visit at month 1. As part of the study small biopsies will be taken from three locations at the baseline visit. The biopsy will be taken from one actinic keratosis, one sun exposed area and one not sun exposed area. A biopsy is a small surgical procedure where a small piece of your skin is removed.
After applying the medications for 30 days you will return to the clinic for your 30 day visit. At this visit you will again have three biopsies taken; one AK, one sun exposed, and one non sun exposed.
placeboDrug
placebo Each subject will be seen for a screening visit as well as a baseline visit and a visit at month 1. As part of the study small biopsies will be taken from three locations at the baseline visit. The biopsy will be taken from, one actinic keratosis, one area that is typically exposed to the sun as well as a site that is typically protected from sun light. A biopsy is a small surgical procedure where a small piece of your skin is removed.
After applying the medications for 30 days you will return to the clinic for your 30 day visit. At this visit you will again have two biopsies taken. One of these biopsies will be from the skin on your arm that was treated with medication for the prior 30 days, and the other biopsy will be from a site that typically is not exposed to the sun.
| Study group | Role | What they receive |
|---|---|---|
| diclofenac once daily | Active comparator | Topical diclofenac, will will be applied onto the skin of one arm, every day for 30 days. Enough medication will be used to cover an area of approximately 4 square inches( a 2 inch by 2 inch square). The medications will come in a tube. The medications will be applied to the same sun exposed site on the arm every day. The research team will provide instructions for the correct application of the treatment. Receives: Drug: topical diclofenac daily |
| placebo | Placebo comparator | The topical medication will will be applied onto the skin of one arm, once daily for 30 days. Enough placebo will be used to cover an area of approximately 4 square inches( a 2 inch by 2 inch square). The placebo will come in a tube. The placebo will be applied to the same sun exposed site on the arm every day. The research team will provide instructions for the correct application of the treatment. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Dosing of topical diclofenac and topical DFMO for the reduction of non melanoma skin cancer biomarkers
The primary outcome measure will be to determine whether subjects randomized to topical diclofenac ± topical DFMO will have a significant reduction (≥40% reduction, p ≤ 0.05) in skin biomarkers associated with development of non melanoma skin cancers after treatment once daily, twice daily or with placebo.
Measured: 1 year
Optimal Dosing of topical diclofenac and topical DFMO for the reduction of actinic keratoses
A secondary outcome will be to determine whether subjects randomized to diclofenac ± DFMO will have fewer actinic keratoses at the end of treatment once daily, twice daily or with placebo.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study start25 Oct 2017
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanoma Skin CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Craig Elmets, University of Alabama at Birmingham
- Investigators
- Craig Elmets, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636569
- Sponsor's protocol ID
- F150814005
- Other IDs
- 2015678
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2015
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Chemoprevention of Skin Cancer Biomarkers
- ClinicalTrials.gov ID
- NCT02636569
- Acronym / sponsor ID
- F150814005
- Conditions
- Non-melanoma Skin Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Men and women (≥ 18 yo)who have been seen as patients in the Dermatology Clinic at the University of Alabama at Birmingham with a history of basal cell or squamous cell carcinoma of the skin and at least 8 actinic keratoses on the upper extremities are potentially eligible for study participation.
We propose to examine one topical medication which is already FDA approved,with a placebo comparator. The purpose of the study is to see if diclofenac applied daily will affect levels of specific biomarkers in the skin that are associated with risk of developing skin cancer. We hope to see these levels decrease with once daily use of this medication. Results from this study will help guide us in a second study where we will look at longer term use of these medications and how they are associated with changes in skin biomarkers that are related to skin cancer. The second longer study will use the dose (once or twice daily topical application of diclofenac and DMFO) that resulted in a decrease in biomarkers, as discovered in this currently proposed study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diclofenac once daily | Active comparator | Drug: topical diclofenac dailyTopical diclofenac, will will be applied onto the skin of one arm, every day for 30 days. Enough medication will be used to cover an area of approximately 4 square inches( a 2 inch by 2 inch square). The medications will come in a tube. The medications will be applied to the same sun exposed site on the arm every day. The research team will provide instructions for the correct application of the treatment. |
| placebo | Placebo comparator | Drug: placeboThe topical medication will will be applied onto the skin of one arm, once daily for 30 days. Enough placebo will be used to cover an area of approximately 4 square inches( a 2 inch by 2 inch square). The placebo will come in a tube. The placebo will be applied to the same sun exposed site on the arm every day. The research team will provide instructions for the correct application of the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- o 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
- Greater than 4 weeks from:
- Prior major surgery for any indication Prior chemotherapy, hormonal therapy or radiation therapy for cancer o 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 areas of actinic damage for the duration of the study. Use of moisturizers/emollients and sunscreens on these areas is allowed.
Key exclusion criteria (12 listed)
- o Within 6 months prior to randomization: Use of oral or intravenous corticosteroids for more than 2 consecutive weeks Use of inhaled corticosteroids for more than 4 consecutive weeks
- o Any of the following in the 4 weeks (or as indicated) 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 (including tamoxifen) Note: treatment with finasteride/dutasteride for BPH does not render a participant ineligible.
- Radiation therapy Topical medications for the treatment of actinic keratosis or skin cancer (retin A, 5-FU, imiquimod) in the 6 months prior to randomization.
- Laser resurfacing, dermabrasion, cryotherapy, chemical peel and electrodissection ± curettage in the 6 months prior to randomization.
- Nasally inhaled corticosteroids (except mometasone - Nasonex) Aspirin (>100 mg/day) - Note: cardioprotective doses (< 100mg/day) are acceptable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical diclofenac dailyAlso: topical diclofenacTopical diclofenac will be applied daily for 30 days. Each subject will be seen for a screening visit as well as a baseline visit and a visit at month 1. As part of the study small biopsies will be taken from three locations at the baseline visit. The biopsy will be taken from one actinic keratosis, one sun exposed area and one not sun exposed area. A biopsy is a small surgical procedure where a small piece of your skin is removed. After applying the medications for 30 days you will return to the clinic for your 30 day visit. At this visit you will again have three biopsies taken; one AK, one sun exposed, and one non sun exposed. | Drug | diclofenac once daily |
| placeboplacebo Each subject will be seen for a screening visit as well as a baseline visit and a visit at month 1. As part of the study small biopsies will be taken from three locations at the baseline visit. The biopsy will be taken from, one actinic keratosis, one area that is typically exposed to the sun as well as a site that is typically protected from sun light. A biopsy is a small surgical procedure where a small piece of your skin is removed. After applying the medications for 30 days you will return to the clinic for your 30 day visit. At this visit you will again have two biopsies taken. One of these biopsies will be from the skin on your arm that was treated with medication for the prior 30 days, and the other biopsy will be from a site that typically is not exposed to the sun. | Drug | placebo |
Primary outcome
Optimal Dosing of topical diclofenac and topical DFMO for the reduction of non melanoma skin cancer biomarkers
Time frame: 1 year
The primary outcome measure will be to determine whether subjects randomized to topical diclofenac ± topical DFMO will have a significant reduction (≥40% reduction, p ≤ 0.05) in skin biomarkers associated with development of non melanoma skin cancers after treatment once daily, twice daily or with placebo.
Optimal Dosing of topical diclofenac and topical DFMO for the reduction of actinic keratoses
Time frame: 1 year
A secondary outcome will be to determine whether subjects randomized to diclofenac ± DFMO will have fewer actinic keratoses at the end of treatment once daily, twice daily or with placebo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Elmets, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing topical diclofenac daily in people with Non-melanoma Skin Cancer, run by University of Alabama at Birmingham at 1 site 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 15 inclusion and 12 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 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Optimal Dosing of topical diclofenac and topical DFMO for the reduction of non melanoma skin cancer biomarkers (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.