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The Effect of Efudex Treatment on Photoaged Skin

NCT00121511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-05-27

No results posted yet for this study

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.

Conditions

  • Photo-aging
  • Keratosis

Interventions

DRUG

Efudex (5-fluorouracil)

Sponsors & Collaborators

Principal Investigators

  • John J Voorhees, MD · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Completion
2007-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00121511 on ClinicalTrials.gov