MedTrace Logo

Topical Chemoprevention of Skin Cancer Biomarkers

NCT02636569 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Non-melanoma Skin Cancer

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Craig Elmets, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2025-12-01
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02636569 on ClinicalTrials.gov