The Effect of Efudex Treatment on Photoaged Skin

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Michigan
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Fluorouracil

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.