Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT02636569
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-09
First Post:
2015-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Topical Chemoprevention of Skin Cancer Biomarkers
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
Topical Chemoprevention of Skin Cancer Biomarkers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: