The Effect of Efudex Treatment on Photoaged Skin

Completed · Not applicable

Conditions studied: Photo-aging, Keratosis

In brief

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.

Key facts

Study ID

NCT00121511

Run by

University of Michigan

People needed

21

Starts

2005-07-01

Expected to finish

2007-07-01

Last updated by the study team

2015-05-27

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 50 or older of either gender.
• Patients must have actinic keratoses
• Patients must have clinical photoaging judged by rhytides, dyspigmentation, poikiloderma, lentigines, skin thinning, and/or telangiectases.
• Subjects must be in generally good health and willing to undergo skin biopsies from the face.
• Subjects must be willing and able to comply with the requirements of the protocol.
• You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.

You may not qualify if…

• Oral retinoid therapy (such as Accutane) within two months of study entry.
• Topical retinoid, imiquimod, or diclofenac therapy within 2 months of study entry.
• Prior laser re-surfacing, chemical peels for actinic keratoses or aging skin.
• Pregnant or nursing subjects.
• Non-compliant subjects.
• Subjects with a significant medical history or concurrent illness that the investigator feels is not safe for study participation.
• Prior systemic treatment with 5-fluorouracil.
• Known history of allergy to lidocaine (numbing medication), 5-fluoruracil, or any other known components of Efudex.

Where it is running

• University of Michigan Department of Dermatology — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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