NCT02636569

Topical Chemoprevention of Skin Cancer Biomarkers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Non-melanoma Skin Cancer

Interventions

Type	Name	Description
DRUG	topical diclofenac daily	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.
DRUG	placebo	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.

Timeline

• Start date: 2017-10-25
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2015-12-22
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study