drugset / Trial / NCT00121511

The Effect of Efudex Treatment on Photoaged Skin

NCT00121511

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2005-07
Primary completion
Completion
2007-07

Drugs

EvaluationDrugModalityDoseRoute
Subject fluorouracil Small molecule Topical