The researchers propose that skin improvements may be seen following a course of Efudex,
(5-fluorouracil), a FDA-approved topical therapy (applied directly to the skin). These
improvements could be the result of both a reduction of actinic keratoses (small red horny
growths or flesh-colored wartlike growths caused by overexposure to ultraviolet radiation or
the sun) and improvement of sun-damaged skin.
In addition, this research study is being done to determine if the expression of p53, a tumor
suppressor gene (its activity stops the formation of tumors), is decreased following Efudex
treatment. Mutations (abnormal changes) in the gene, called p53, are associated with a
certain type of skin cancer. In addition, p53-mutated genes are known to exist in
non-cancerous sun-damaged skin. Thus, the presence of p53 mutations may serve as a marker for
both sun damage and an elevated risk of developing skin cancer.
Phase:
N/A
Details
Lead Sponsor:
University of Michigan
Collaborators:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.